U.S. patent number 9,081,382 [Application Number 13/837,811] was granted by the patent office on 2015-07-14 for autonomous vehicle comprising extracorporeal blood treatment machine.
This patent grant is currently assigned to Fresenius Medical Care Holdings, Inc.. The grantee listed for this patent is FRESENIUS MEDICAL CARE HOLDINGS, INC.. Invention is credited to Matthew Doyle, Lee Tanenbaum, John Tong.
United States Patent |
9,081,382 |
Doyle , et al. |
July 14, 2015 |
Autonomous vehicle comprising extracorporeal blood treatment
machine
Abstract
An autonomous vehicle is provided that includes an autonomous
vehicle control system, a dialysis machine, and an interface
providing an electrical communication between the dialysis machine
and the autonomous vehicle control system. The dialysis machine is
configured to perform a dialysis treatment on a patient while the
autonomous vehicle is under the control of the autonomous vehicle
control system. A vehicle is also provided that includes a
navigation system, a dialysis machine, and an interface between the
navigation system and the dialysis machine. The vehicle can be a
car, a train, a plane, or another vehicle.
Inventors: |
Doyle; Matthew (Pleasant Hill,
CA), Tanenbaum; Lee (Walnut Creek, CA), Tong; John
(San Mateo, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
FRESENIUS MEDICAL CARE HOLDINGS, INC. |
Waltham |
MA |
US |
|
|
Assignee: |
Fresenius Medical Care Holdings,
Inc. (Waltham, MA)
|
Family
ID: |
50489399 |
Appl.
No.: |
13/837,811 |
Filed: |
March 15, 2013 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20140277894 A1 |
Sep 18, 2014 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G05D
1/00 (20130101); B60W 50/0098 (20130101); G01C
21/3407 (20130101); B60W 10/04 (20130101); B60W
30/1886 (20130101); G01C 21/3453 (20130101); A61M
1/16 (20130101); A61M 1/1601 (20140204); G05D
1/0088 (20130101); B60W 10/30 (20130101); B60W
40/12 (20130101); A61M 1/14 (20130101); A61M
1/367 (20130101); B60W 10/26 (20130101); A61M
2205/3393 (20130101); A61M 2205/825 (20130101); A61M
2205/18 (20130101); A61M 2205/3331 (20130101); A61M
2209/08 (20130101); Y02A 90/26 (20180101); A61M
2205/8262 (20130101); G16H 20/40 (20180101); A61M
2205/3553 (20130101); A61M 2205/3334 (20130101); A61M
2205/8206 (20130101); Y02A 90/10 (20180101); A61M
2205/3379 (20130101); A61M 2205/3576 (20130101); A61M
2205/3666 (20130101); A61M 2205/502 (20130101) |
Current International
Class: |
A61M
1/14 (20060101); A61M 1/16 (20060101); G05D
1/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
202011052487 |
|
Jun 2012 |
|
DE |
|
2003102830 |
|
Apr 2003 |
|
JP |
|
Other References
International Search Report and Written Opinion issued in
corresponding International Patent Application No.
PCT/US2014/023832, dated Jul. 28, 2014 (13 pages). cited by
applicant .
Wikipedia "Google Driverless Car," last modified Mar. 28, 2013.
cited by applicant.
|
Primary Examiner: Tarcza; Thomas
Assistant Examiner: Goldman; Richard
Attorney, Agent or Firm: Kilyk & Bowersox, P.L.L.C.
Claims
What is claimed is:
1. An autonomous vehicle comprising: an autonomous vehicle control
system comprising a first input device configured to accept a
destination input, the autonomous vehicle control system configured
to calculate a travel duration for the autonomous vehicle to reach
the destination; a dialysis machine comprising a control unit and a
second input device configured to accept a prescription therapy
input, the control unit configured to accept the travel duration
from the autonomous vehicle control system and to calculate a rate
of treatment to complete the inputted prescription therapy within
the travel duration, the dialysis machine configured to perform a
dialysis treatment on a patient while the autonomous vehicle is
under the control of the autonomous vehicle control system; and an
interface providing an electrical communication between the
dialysis machine and the autonomous vehicle control system.
2. The autonomous vehicle of claim 1, wherein the dialysis machine
further comprises a transmitter and a receiver, the transmitter is
configured to transmit wireless signals pertaining to the dialysis
machine, and the receiver is configured to receive wireless signals
pertaining to the dialysis machine.
3. The autonomous vehicle of claim 1, further comprising a vehicle
electrical system, a car battery, an alternator for charging the
car battery during operation of the vehicle, and a backup battery
dedicated to the dialysis machine, wherein the backup battery is in
electrical communication with the alternator and the vehicle
electrical system is configured to charge the backup battery during
operation of the vehicle.
4. The autonomous vehicle of claim 3, wherein the vehicle
electrical system comprises an ignition switch and an ignition
switch bypass circuit configured to provide battery power from the
backup battery to the dialysis machine in the event that the
ignition switch is turned off during a prescription therapy.
5. The autonomous vehicle of claim 2, further comprising a dialysis
machine alarm system configured to determine the nearest hospital,
dialysis clinic, urgent care center, or other emergency care
center, using the wireless signals, and the autonomous vehicle
control system is configured to navigate the autonomous vehicle to
the nearest hospital, dialysis clinic, urgent care center, or other
emergency care center, for corrective measures.
6. The autonomous vehicle of claim 1, wherein the dialysis machine
comprises a blood flow circuit, the blood flow circuit comprising:
a blood pump; a dialyzer; an arterial tube configured to be
connectable to a patient blood flow system; a venous tube
configured to be connectable to a patient blood flow system; and an
emergency state alarm system operably configured to indicate an
emergency condition, and wherein the emergency state alarm system
is configured such that, upon activation, the autonomous vehicle
control system navigates the autonomous vehicle to a hospital, a
dialysis clinic, an urgent care center, or another emergency care
center, for corrective measures.
7. The autonomous vehicle of claim 1, wherein the dialysis machine
comprises at least one blood pump and an alarm system, the alarm
system being configured to stop operation of at least one blood
pump in response to receiving a low level alarm signal, and the
autonomous vehicle control system being configured to navigate the
autonomous vehicle to the nearest emergency care center in response
to receiving an emergency state alarm signal from the alarm
system.
8. The autonomous vehicle of claim 1, further comprising a vehicle
interior, wherein the dialysis machine comprises a control unit and
further comprises a receiver fixedly attached to the vehicle
interior and configured to receive disposable dialysis
equipment.
9. The autonomous vehicle of claim 8, wherein the dialysis machine
further comprises: a door having an interior face; and a housing
built into the interior of the vehicle and including a panel,
wherein the housing and the panel together define a recessed region
configured to receive the interior face of the door, and the
receiver is fixedly attached to the panel.
10. The autonomous vehicle of claim 8, wherein the autonomous
vehicle comprises a dash board and the control unit is mounted in
or on the dash board.
11. The autonomous vehicle of claim 8, further comprising a catch
basin, wherein the vehicle interior comprises a floor, the dialysis
machine comprises a plurality of connectors, the catch basin is
secured to the floor, and the catch basin is positioned with
respect to the dialysis machine to catch liquid that drips from the
connectors in the event that liquid drips from one or more of the
plurality of connectors.
12. A vehicle comprising: a vehicle navigation system; an energy
source; an energy source level sensor; a dialysis machine
configured to perform a dialysis treatment on a patient while the
vehicle is operating, the dialysis machine comprising a control
unit configured to receive a signal sent from the energy source
level sensor and to calculate the amount of energy needed to
operate the autonomous vehicle and the dialysis machine together
for a time needed to complete the dialysis treatment; and an
interface providing an electrical communication between the
dialysis machine and the vehicle navigation system.
13. The vehicle of claim 12, wherein the vehicle navigation system
comprises a first input device configured to accept a destination
input, the vehicle navigation system is configured to calculate a
travel duration for the vehicle to reach the desired destination,
the dialysis machine comprises a second input device configured to
receive a prescription therapy input for the dialysis treatment,
and the control unit is configured to calculate a rate of treatment
that would be required to complete the inputted prescription
therapy within the amount of time, calculated by the vehicle
navigation system, needed to complete the dialysis treatment.
14. The vehicle of claim 12, further comprising a vehicle
electrical system, a car battery, an alternator for charging the
car battery during operation of the vehicle, and a backup battery
dedicated to the dialysis machine, wherein the backup battery is in
electrical communication with the alternator and the vehicle
electrical system is configured to charge the backup battery during
operation of the vehicle.
15. The vehicle of claim 14, wherein the vehicle electrical system
comprises an ignition switch and an ignition switch bypass circuit
configured to provide battery power from the backup battery to the
dialysis machine in the event that the ignition switch is turned
off.
16. The vehicle of claim 12, wherein the dialysis machine further
comprises at least one blood pump and an alarm system, the alarm
system being configured to stop operation of the at least one blood
pump in response to receiving a low level alarm signal, and the
vehicle navigation system being configured to navigate the vehicle
to the nearest emergency care center in response to receiving an
emergency state alarm signal from the alarm system.
17. The vehicle of claim 12, further comprising an engine, the
energy source comprising a fuel source for the engine, and the
energy source sensor comprising a fuel sensor configured to sense
the amount of fuel available for the engine, wherein the control
unit comprises a user interface configured to enable a user to
input a prescription therapy to the dialysis machine, the interface
between the dialysis machine and the vehicle navigation system
comprises an electrical communication between the fuel sensor and
the control unit, the prescription therapy includes a value for the
amount of time required to carry out the prescription therapy, the
fuel sensor is configured to send a signal to the control unit
indicating the amount of fuel available to power the engine, and
the control unit is configured to notify the user if there is
insufficient fuel to power the engine for the amount of time that
would be required to carry out the prescription therapy.
18. The vehicle of claim 12, further comprising a battery-operated
motive engine motor, the energy source comprises a battery
configured to supply battery power to the engine motor, and the
energy source level sensor comprises a battery sensor configured to
sense the amount of battery power available for the engine motor,
wherein the control unit comprises a user interface configured to
enable a user to input a prescription therapy to the dialysis
machine, the interface between the dialysis machine and the vehicle
navigation system comprises an electrical communication between the
battery sensor and the control unit, the prescription therapy
includes a value for the amount of time required to carry out the
prescription therapy, the battery sensor is configured to send a
signal to the control unit indicating the amount of battery power
available to power the engine motor, and the control unit is
configured to notify the user if there is insufficient battery
power to power the engine motor for the amount of time that would
be required to carry out the prescription therapy.
19. The vehicle of claim 12, wherein the vehicle comprises an
automobile.
20. The vehicle of claim 12, wherein the energy source comprises
fuel, battery power, or a combination thereof.
21. The vehicle of claim 12, wherein the control unit is configured
to notify the user if there is insufficient energy to power the
vehicle for the time needed to complete the dialysis treatment.
22. An autonomous vehicle comprising: a dialysis machine comprising
at least one blood pump, and an alarm system configured stop
operation of the at least one blood pump in response to receiving
an emergency state alarm signal; an autonomous vehicle control
system configured to receive the emergency state alarm signal and
navigate the autonomous vehicle to the nearest emergency care
center; and an interface providing an electrical connection between
the autonomous vehicle control system and the dialysis machine.
Description
FIELD
The present invention relates to autonomous vehicles and machines
and systems configured to carry out extracorporeal blood treatment
therapies.
BACKGROUND OF THE INVENTION
As vehicles move more and more toward autonomous operation, vehicle
operators are gaining more and more freedom to accomplish tasks and
concentrate on matters other than driving the vehicle. Although
portable dialysis machines are known, no vehicle has been equipped
with a dialysis machine that is interfaced with a vehicle
navigation system or with an autonomous vehicle control system.
SUMMARY OF THE PRESENT INVENTION
According to one or more embodiments of the present invention, an
autonomous vehicle is provided that comprises an autonomous vehicle
control system, a dialysis machine, and an interface providing an
electrical communication between the dialysis machine and the
autonomous vehicle control system. The autonomous vehicle can
comprise an automobile, a hybrid car, an airplane, a train, a
submarine, a helicopter, a ship, a boat, a spacecraft, or any other
vehicle. The dialysis machine can be configured to perform a
dialysis treatment on a patient while the autonomous vehicle is
under the control of the autonomous vehicle control system. The
autonomous vehicle can comprise at least one battery for powering
one or more components of the autonomous vehicle, and the interface
can provide an electrical communication between the at least one
battery and the dialysis machine. The autonomous vehicle can
further comprise a vehicle electrical system, and the dialysis
machine can be hardwired into the vehicle electrical system. The
autonomous vehicle control system can comprise an input device with
which a user can input a desired destination. The autonomous
vehicle control system can be configured to calculate the amount of
time required for the autonomous vehicle to reach the desired
destination. The dialysis machine controller unit can comprise an
input device with which a user can input a desired prescription
therapy, and the dialysis machine controller unit can be configured
to calculate a rate of treatment that would be required to complete
the inputted prescription therapy within the amount of time
calculated by the autonomous vehicle control system. The dialysis
machine controller unit can further be configured to determine
whether the calculated rate of treatment is within acceptable
limits, and if so, the dialysis machine controller unit can be
configured to permit the dialysis machine to carry out the inputted
prescription therapy. If the controller unit determines that the
calculated rate of treatment is not within acceptable limits, the
dialysis machine controller unit can further be configured to
prevent the dialysis machine from carrying out the inputted
prescription therapy.
The present invention also encompasses vehicles that are not
autonomous, but that include a navigation system, a dialysis
machine, and an interface providing an electrical communication
between the dialysis machine and the navigation system.
It is to be understood that both the foregoing general description
and the following detailed description are exemplary and
explanatory only and are intended to provide a further explanation
of the present invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of the interior of a vehicle in accordance
with one or more embodiments of the present invention, showing a
dialysis machine mounted, in-part, in the vehicle dashboard.
FIG. 2 is a front view of a vehicle seat back incorporating a
dialysis machine, in accordance with various embodiments of the
present invention.
FIG. 3 is a flow chart depicting a process for enabling users to
input a prescribed therapy for dialysis, to be completed while
traveling to a destination, and options that can be selected by the
user if the desired therapy is not available.
FIG. 4 is a flow chart depicting a process for enabling users to
input a prescribed therapy to be completed while traveling to a
destination, and options that can be selected by the user if there
is insufficient fuel or power.
FIG. 5 is a flow chart depicting a process for enabling actions in
response to an alarm signal, including different actions depending
on a state of the alarm signal.
FIG. 6 is an exemplary fluid circuit diagram that can be used in a
vehicle and method in accordance with the present invention;
FIG. 7 is another exemplary fluid circuit diagram that can be used
in a vehicle and method in accordance with the present
invention;
FIG. 8 is a schematic of diagram of an exemplary manifold that can
be used in a vehicle and method in accordance with the present
invention;
FIG. 9 is a front view of an embodiment of a controller unit for a
dialysis system showing the door open and the manifold
installed;
FIG. 10 is a diagram of an exemplary disconnect monitoring
system;
FIG. 11 is a flowchart defining an exemplary disconnection
detection process;
FIG. 12 is yet another exemplary fluid circuit diagram that can be
used in a vehicle and method in accordance with the present
invention;
FIG. 13 is yet another exemplary fluid circuit diagram that can be
used in a vehicle and method in accordance with the present
invention;
FIG. 14 is yet another exemplary fluid circuit diagram that can be
used in a vehicle and method in accordance with the present
invention;
FIG. 15 is a flowchart depicting a process for enabling users to
accurately add additives in a dialysis machine that can be used in
a vehicle and method in accordance with the present invention;
FIG. 16 is a schematic diagram showing a disposable kit comprising
a manifold and a dialyzer attached to a plurality of tubes, which
can be used in a vehicle and method in accordance with the present
invention;
FIG. 17 is yet another exemplary fluid circuit diagram that can be
used in a vehicle and method in accordance with the present
invention;
FIG. 18 is yet another exemplary fluid circuit diagram showing a
priming mode of operation that can be used in a vehicle and method
in accordance with the present invention; and
FIG. 19 is a schematic diagram of yet another embodiment of an
exemplary manifold that can be used in a vehicle and method in
accordance with the present invention.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
According to one or more embodiments of the present invention, an
autonomous vehicle is provided that comprises an autonomous vehicle
control system, a dialysis machine, and an interface providing an
electrical communication between the dialysis machine and the
autonomous vehicle control system. The autonomous vehicle can
comprise an automobile, a hybrid car, an airplane, a train, a
submarine, a helicopter, a ship, a boat, a spacecraft, or any other
vehicle. The dialysis machine can be configured to perform a
dialysis treatment on a patient while the autonomous vehicle is
under the control of the autonomous vehicle control system. The
autonomous vehicle can comprise at least one battery for powering
one or more components of the autonomous vehicle, and the interface
can provide an electrical communication between the at least one
battery and the dialysis machine. The autonomous vehicle can
further comprise a vehicle electrical system, and the dialysis
machine can be hardwired into the vehicle electrical system. The
autonomous vehicle control system can comprise an input device with
which a user can input a desired destination. The autonomous
vehicle control system can be configured to calculate the amount of
time required for the autonomous vehicle to reach the desired
destination. The dialysis machine controller unit can comprise an
input device with which a user can input a desired prescription
therapy, and the dialysis machine controller unit can be configured
to calculate a rate of treatment that would be required to complete
the inputted prescription therapy within the amount of time
calculated by the autonomous vehicle control system. The dialysis
machine controller unit can further be configured to determine
whether the calculated rate of treatment is within acceptable
limits, and if so, the dialysis machine controller unit can be
configured to permit the dialysis machine to carry out the inputted
prescription therapy. If the controller unit determines that the
calculated rate of treatment is not within acceptable limits, the
dialysis machine controller unit can further be configured to
prevent the dialysis machine from carrying out the inputted
prescription therapy.
The input device for the autonomous vehicle control system can
comprise a display screen in the autonomous vehicle, and the input
device for the dialysis machine can comprise the same display
screen or a different display screen. The dialysis machine can
further comprise a transmitter and a receiver, wherein the
transmitter is configured to transmit wireless signals pertaining
to the dialysis machine, and the receiver is configured to receive
wireless signals pertaining to the dialysis machine. As such, a
patient can be constant contact with a monitoring service or
clinic, during a therapy.
The autonomous vehicle can comprise an engine, and the autonomous
vehicle control system can be configured to maintain the engine in
a running condition while the dialysis machine is operating. The
autonomous vehicle can comprise a battery-operated drive motor
configured to move the autonomous vehicle. The autonomous vehicle
can further comprise a vehicle electrical system, a car battery, an
alternator for charging the car battery during operation of the
vehicle, and a backup battery dedicated to the dialysis machine.
Then backup battery can be in electrical communication with the
alternator, and the vehicle electrical system can be configured to
charge the backup battery during operation of the vehicle. The
vehicle electrical system can comprise an ignition switch and an
ignition switch bypass circuit configured to provide battery power
from the backup battery to the dialysis machine in the event that
the ignition switch is turned off during a prescription
therapy.
The dialysis machine can comprise a blood flow circuit comprising:
a blood pump; a dialyzer; an arterial tube; and a venous tube. The
arterial tube and the venous tube can be configured to be
connectable to a patient blood flow system. The dialysis machine
can further comprise a dialysate flow circuit comprising: a
dialysate pump; a fresh dialysate tube; and a spent dialysate tube,
wherein the fresh dialysate tube and the spent dialysate tube are
configured to be connectable to the dialyzer. The dialysis machine
can also comprise an alarm system configured to transmit a signal,
indicative of an alarm condition, to a receiver. The receiver can
comprise a receiver at a hospital, a receiver at a clinic, a
receiver at a medical monitoring service, or a receiver at another
emergency care center. The dialysis machine alarm system can be
configured to determine the nearest hospital, dialysis clinic,
urgent care center, or other emergency care center, and navigate
the autonomous vehicle to the nearest hospital, dialysis clinic,
urgent care center, or other emergency care center, for corrective
measures. Navigation to an emergency care center can be instigated
if an emergency state alarm condition is triggered. The dialysis
machine alarm system can comprise at least one of an arterial
chamber transducer and a venous chamber transducer, configured for
monitoring blood flow pressure changes. In an example, the dialysis
machine can comprise at least one blood pump, the dialysis machine
alarm system can comprise an arterial chamber transducer in a blood
flow circuit, and the arterial chamber transducer can be configured
such that, if it registers a pressure change that is outside of a
threshold limit, the alarm system stops the at least one blood
pump. Similarly, the dialysis machine can comprise at least one
blood pump, the dialysis machine alarm system can comprise a venous
chamber transducer in a blood flow circuit, and the venous chamber
transducer can be configured such that, if it registers a pressure
change that is outside of a threshold limit, the alarm system stops
the at least one blood pump.
The dialysis machine can comprise a blood flow circuit comprising:
a blood pump; a dialyzer; an arterial tube configured to be
connectable to a patient blood flow system; a venous tube
configured to be connectable to a patient blood flow system; and an
emergency state alarm system operably configured to indicate an
emergency condition. The emergency state alarm system can be
configured such that, upon activation, the autonomous vehicle
control system navigates the autonomous vehicle to a hospital, a
dialysis clinic, an urgent care center, or another emergency care
center, for corrective measures. For example, the autonomous
vehicle control system can be configured such that, upon activation
of the emergency state alarm system, the autonomous vehicle control
system determines the nearest emergency care center, and navigates
the autonomous vehicle to the nearest emergency care center, for
corrective measures. The autonomous vehicle control system can be
configured such that, upon activation of the emergency state alarm
system, the autonomous vehicle control system determines the
nearest emergency care center, sends a notification to the nearest
emergency care center so determined, and navigates the autonomous
vehicle to the nearest emergency care center for corrective
measures, the notification pertaining to the emergency condition
that triggered the activation of the emergency state alarm
system.
The dialysis machine can further comprise an arterial tube pressure
sensor, a venous tube pressure sensor, and an alarm system
configured to indicate an alarm condition when one or both of the
arterial tube pressure sensor and the venous tube pressure sensor
senses a pressure that exceeds a maximum respective threshold value
or that drops below a minimum respective threshold value. The
dialysis machine can comprise at least one blood pump and an alarm
system, wherein the alarm system is configured to (1) stop
operation of at least one blood pump in response to receiving a low
level alarm signal, and (2) navigate the autonomous vehicle to the
nearest emergency care center in response to receiving an emergency
state alarm signal.
The autonomous vehicle can further comprise an engine, a fuel
source for the engine, a fuel sensor configured to sense the amount
of fuel available for the engine, and a dialysis controller for the
dialysis machine. The dialysis controller can comprise a user
interface configured to enable a user to input a prescription
therapy to the dialysis machine. The interface between the dialysis
machine and the autonomous vehicle control system can comprise an
electrical communication between the fuel sensor and the dialysis
controller. The fuel sensor can be configured to send a signal to
the dialysis controller indicating the amount of fuel available to
power the engine, and the dialysis controller can be configured to
notify the user if there is insufficient fuel to power the engine
for the amount of time that would be required to carry out the
prescription therapy. The dialysis controller can be configured to
calculate the amount of fuel that would be required to operate the
autonomous vehicle for a period of time required to carry out the
prescription therapy, and then notify the user if there is
insufficient fuel to power the engine for the amount of time that
would be required to carry out the prescription therapy. The
dialysis controller can be configured to calculate the amount of
fuel based on a measured current rate of consumption and based on a
predicted rate of consumption that would be required to operate the
autonomous vehicle and the dialysis machine together for the amount
of time that would be required to carry out the prescription
therapy. The dialysis controller can further be configured to
prevent the dialysis machine from carrying out the prescription
therapy if there is insufficient fuel to power the engine for the
amount of time that would be required to carry out the prescription
therapy.
The autonomous vehicle can comprise a battery-operated motive
engine, a battery configured to supply battery power to the engine,
a battery sensor configured to sense the amount of battery power
available for the engine, and a dialysis controller for the
dialysis machine. The dialysis controller can comprise a user
interface configured to enable a user to input a prescription
therapy to the dialysis machine. The interface between the dialysis
machine and the autonomous vehicle control system can comprise an
electrical communication between the battery sensor and the
dialysis controller, and the battery sensor can be configured to
send a signal to the dialysis controller indicating the amount of
battery power available to power the engine. The dialysis
controller can be configured to notify the user if there is
insufficient battery power to power the engine for the amount of
time that would be required to carry out the prescription therapy.
The dialysis controller can be configured to calculate the amount
of battery power that would be required to operate the autonomous
vehicle for a period of time required to carry out the prescription
therapy, and then notify the user if there is insufficient battery
power to power the engine for the amount of time that would be
required to carry out the prescription therapy. Moreover, the
dialysis controller can be configured to calculate the amount of
battery power based on a measured current rate of consumption and
based on a predicted rate of consumption that would be required to
operate the autonomous vehicle and the dialysis machine together
for the amount of time that would be required to carry out the
prescription therapy. The dialysis controller can further be
configured to prevent the dialysis machine from carrying out the
prescription therapy if there is insufficient battery power to
power the engine for the amount of time that would be required to
carry out the prescription therapy.
The dialysis machine can comprise a recirculating dialysate fluid
circuit and a sorbent cartridge in fluid communication with the
recirculating dialysate fluid circuit. The autonomous vehicle can
comprise an engine and an engine cooling system. The dialysis
machine can comprise at least one fluid flow path, and the
interface can be configured to use heat from the engine cooling
system to heat one or more fluids flowing through the at least one
fluid flow path. The engine cooling system can comprise an engine
coolant flow path, and the interface can provide a heat-exchange
communication between the engine coolant flow path and the at least
one fluid flow path of the dialysis machine. The at least one fluid
flow path of the dialysis machine can comprise a dialysate flow
path and the interface can comprise a heat exchanger that is in
thermal communication with the engine coolant flow path and the
dialysate flow path. The dialysis machine can comprise a dialysate
fluid flow path and a heater that is in thermal communication with
the dialysate fluid flow path to heat dialysate fluid in the
dialysate fluid flow path. The heater can comprise a resistance
heater, an electrical heater, a radiant heater, a Peltier heater,
or the like.
According to one or more embodiments of the present invention, an
autonomous vehicle is provided that comprises a vehicle interior,
an autonomous vehicle control system, a dialysis machine, and an
interface providing an electrical communication between the
dialysis machine and the autonomous vehicle control system. The
dialysis machine can be configured to perform a dialysis treatment
on a patient while the autonomous vehicle is under the control of
the autonomous vehicle control system. The dialysis machine can
comprise, for example: a control unit; and a receiver fixedly
attached to the vehicle interior and configured to receive
disposable dialysis equipment. The autonomous vehicle can further
comprise a vehicle electrical system and the dialysis machine can
be hardwired into the vehicle electrical system. The dialysis
machine can include disposable dialysis equipment, for example,
comprising a molded plastic manifold defining a first flow path and
a second flow path that is fluidically isolated from the first flow
path. The molded plastic manifold can be received by the receiver.
The disposable dialysis equipment can further comprise a dialyzer
and the molded plastic manifold can be bonded to a plurality of
tubes, wherein at least two of the tubes are in fluid communication
with the dialyzer. A dialyzer mount can be fixedly attached to the
vehicle interior and configured to fixedly secure the dialyzer with
respect to the dialysis machine. The disposable dialysis equipment
can further comprise a sorbent cartridge, and the molded plastic
manifold can be bonded to a plurality of tubes, at least two of
which are in fluid communication with the sorbent cartridge. A
cartridge mount can be fixedly attached to the vehicle interior and
configured to fixedly secure the sorbent cartridge with respect to
the dialysis machine.
The dialysis machine can further comprise: a door having an
interior face; and a housing built into the interior of the vehicle
and including a panel. The housing and the panel can be configured
so that together they define a recessed region adapted to receive
the interior face of the door. The receiver can be fixedly attached
to the panel. The panel can be configured to provide access to a
plurality of pumps, and the dialysis machine can further comprise
pumps, for example, at least one blood pump and at least one
dialysate pump. The pumps can be operably positioned in
substantially parallel alignment with one another, and the panel
can be configured to provide access to the pumps. The interior face
of the door can comprise pump shoes that align with the pumps when
the door is in a closed position. The door can have an exterior
face and the control unit can be mounted on the exterior face of
the door.
The dialysis machine can further comprise a surface for receiving a
container of fluid. The surface can be built into a floor or a seat
of the autonomous vehicle. A scale can be integrated into the
surface and configured to weigh a container of fluid disposed on
the surface. A heater can be provided in thermal communication with
the surface, and a conductivity sensor can be provided in
electromagnetic communication with the surface. In some cases, the
autonomous vehicle comprises a dash board and the control unit is
mounted in or on the dash board. The control unit can comprise a
graphical user interface, and the graphical user interface can be
mounted in or on the dash board. The dialysis machine can further
comprise a plurality of connectors, and an electronic circuit
element. The electronic circuit element can comprise a processor
module, a data acquisition module in electrical communication with
the processor module, and an interface module in electronic
communication with the data acquisition module. The electronic
circuit element can comprise a video module, a touch panel element
in electrical communication with the video module, a pulse display,
one or more pressure displays, an electrocardiogram display, a
combination thereof, or the like. The plurality of connectors can
comprise a blood pressure device input, a pulse device input, an
EKG device input, a combination thereof, or the like. The
autonomous vehicle can further comprise a catch basin, the vehicle
interior can comprise a floor, the dialysis machine can comprise a
plurality of connectors, the catch basin can be secured to the
floor, and the catch basin can be positioned with respect to the
dialysis machine to catch liquid that drips from the connectors in
the event that liquid drips from one or more of the plurality of
connectors. The catch basin can be removably secured to the floor.
The catch basin can be removably secured to a seat in the
vehicle.
According to one or more embodiments of the present invention, the
vehicle can be, but is not necessarily, an autonomous vehicle.
Although referred to below as a non-autonomous vehicle to
distinguish from some of the embodiments described above, it is to
be understood that the features described below could similarly be
incorporated into an autonomous vehicle and doing so is well within
the scope of the present invention.
The non-autonomous vehicle can comprise an automobile, a hybrid
car, an airplane, a train, a submarine, a helicopter, a ship, a
boat, a spacecraft, or the like. The vehicle can comprise a vehicle
navigation system, a dialysis machine, and an interface providing
an electrical communication between the dialysis machine and the
vehicle navigation system. The dialysis machine can be configured
to perform a dialysis treatment on a patient while the vehicle is
operating. The dialysis machine can comprise: a controller; a door
having an interior face; a housing built into the interior of the
vehicle and including a panel, wherein the housing and the panel
define a recessed region that faces the interior face of the door;
and a disposables circuit receiver attached to the panel. The
vehicle can further comprise a vehicle electrical system, and the
dialysis machine can be hardwired into the vehicle electrical
system. The vehicle can comprise at least one battery for powering
one or more components of the vehicle, and the interface can
provide an electrical communication between the at least one
battery and the dialysis machine.
The vehicle navigation system can comprise an input device with
which a user can input a desired destination. The vehicle
navigation system can be configured to calculate the amount of time
required for the vehicle to reach the desired destination. The
dialysis machine can comprise an input device with which a user can
input a desired prescription therapy. The dialysis machine can also
comprise a control unit configured to calculate a rate of treatment
that would be required to complete the inputted prescription
therapy within the amount of time calculated by the vehicle
navigation system. The dialysis machine control unit can further be
configured to determine whether the calculated rate of treatment is
within acceptable limits, and if so, the dialysis machine control
unit can be configured to permit the dialysis machine to carry out
the inputted prescription therapy. If the control unit determines
that the calculated rate of treatment is not within acceptable
limits, the dialysis machine control unit can be configured to
prevent the dialysis machine from carrying out the inputted
prescription therapy.
The dialysis machine can further comprise a transmitter and a
receiver. The transmitter can be configured to transmit wireless
signals pertaining to the dialysis machine, and the receiver can be
configured to receive wireless signals pertaining to the dialysis
machine. The vehicle can comprise a vehicle electrical system, a
battery, an alternator for charging the battery during operation of
the vehicle, and a backup battery dedicated to the dialysis
machine. The backup battery can be in electrical communication with
the alternator and the vehicle electrical system can be configured
to charge the backup battery during operation of the vehicle. The
vehicle electrical system can comprise an ignition switch and an
ignition switch bypass circuit configured to provide battery power
from the backup battery to the dialysis machine in the event that
the ignition switch is turned off.
Similar to the autonomous vehicles discussed above, the dialysis
machine in the non-autonomous vehicle can also comprise an
emergency state alarm system operably configured to indicate an
emergency condition. Upon activation of the emergency state alarm
system, the vehicle navigation system can be caused to navigate the
vehicle to an emergency care center, for corrective measures. Upon
activation of the emergency state alarm system, the vehicle
navigation system can determine the nearest emergency care center
and navigate the vehicle to the nearest emergency care, center for
corrective measures. In some cases, upon activation of the
emergency state alarm system, the vehicle control system can
determine the nearest emergency care center, send a notification to
the nearest emergency care center so determined, and navigate the
vehicle to the nearest emergency care center, for corrective
measures. The notification can pertain to the emergency condition
that triggered the activation of the emergency state alarm
system.
The dialysis machine can further comprise an arterial tube pressure
sensor, a venous tube pressure sensor, and an alarm system
configured to indicate an alarm condition when one or both of the
arterial tube pressure sensor and the venous tube pressure sensor
senses a pressure that exceeds a maximum respective threshold value
or that drops below a minimum respective threshold value. The
dialysis machine can comprise at least one blood pump, and such an
alarm system. The alarm system can be configured to (1) stop
operation of the at least one blood pump in response to receiving a
low level alarm or a high level alarm signal, and (2) navigate the
vehicle to the nearest emergency care center in response to
receiving an emergency state alarm signal. The dialysis machine
alarm system can further be configured to transmit a signal,
indicative of an alarm condition, to a receiver. The receiver can
comprise a receiver at a hospital, a receiver at a clinic, a
receiver at a medical monitoring service, or a receiver at another
emergency care center. The dialysis machine can include an alarm
system that comprises at least one of an arterial chamber
transducer and a venous chamber transducer, in a blood flow path,
which are configured for monitoring blood flow pressure
changes.
The vehicle can comprise an engine, a fuel source for the engine, a
fuel sensor configured to sense the amount of fuel available for
the engine, and a dialysis control unit for the dialysis machine.
The dialysis control unit can comprise a user interface configured
to enable a user to input a prescription therapy to the dialysis
machine, the interface between the dialysis machine and the vehicle
navigation system can comprise an electrical communication between
the fuel sensor and the dialysis control unit. The fuel sensor can
be configured to send a signal to the dialysis control unit
indicating the amount of fuel available to power the engine. The
dialysis control unit can be configured to notify the user if there
is insufficient fuel to power the engine for the amount of time
that would be required to carry out the prescription therapy. In
some cases, the dialysis control unit can be configured to
calculate the amount of fuel that would be required to operate the
vehicle for a period of time required to carry out the prescription
therapy, and then notify the user if there is insufficient fuel to
power the engine for the amount of time that would be required to
carry out the prescription therapy. The dialysis control unit can
be configured to calculate the amount of fuel based on a measured
current rate of consumption and based on a predicted rate of
consumption that would be required to operate the vehicle and the
dialysis machine together for the amount of time that would be
required to carry out the prescription therapy. The dialysis
control unit can be configured to prevent the dialysis machine from
carrying out the prescription therapy if there is insufficient fuel
to power the engine for the amount of time that would be required
to carry out the prescription therapy.
In cases where the vehicle comprises a battery-operated motive
engine, a battery is provided to supply battery power to the
engine. A battery sensor can be configured to sense the amount of
battery power available for the engine, and a dialysis control unit
for the dialysis machine can comprise a user interface configured
to enable a user to input a prescription therapy to the dialysis
machine. The interface between the dialysis machine and the vehicle
navigation system can comprise an electrical communication between
the battery sensor and the dialysis control unit. The battery
sensor can be configured to send a signal to the dialysis control
unit indicating the amount of battery power available to power the
engine, and the dialysis control unit can be configured to notify
the user if there is insufficient battery power to power the engine
for the amount of time that would be required to carry out the
prescription therapy. The dialysis control unit can be configured
to calculate the amount of battery power that would be required to
operate the vehicle for a period of time required to carry out the
prescription therapy, and then notify the user if there is
insufficient battery power to power the engine for the amount of
time that would be required. The dialysis control unit can be
configured to calculate the amount of battery power based on a
measured current rate of consumption and based on a predicted rate
of consumption that would be required to operate the vehicle and
the dialysis machine together for the amount of time that would be
required to carry out the prescription therapy. The dialysis
control unit can further be configured to prevent the dialysis
machine from carrying out the prescription therapy if there is
insufficient battery power to power the engine for the amount of
time that would be required to carry out the therapy.
Similar to the autonomous vehicles discussed above, the
non-autonomous vehicle can further comprise a catch basin. The
vehicle interior can comprise a floor, the dialysis machine can
comprise a plurality of connectors, and the catch basin can be
secured to the floor in a position with respect to the dialysis
machine such that the catch basin can catch any liquid that drips
from the connectors in the event that one or more of the connectors
leaks. The catch basin can be removably secured to the floor,
removably secured to a seat in the vehicle, removably secured in a
trunk of the vehicle, or the like.
The vehicle can further comprise a dash board, and the dialysis
machine can comprise a graphical user interface mounted in or on
the dash board. The dialysis machine can further comprise a front
panel having associated therewith an electronic circuit element.
The electronic circuit element can comprise a processor module, a
data acquisition module in electrical communication with the
processor module, an interface module in electronic communication
with the data acquisition module, a video module, a touch panel
element in electrical communication with the video module, a pulse
display, an EKG display, a combination thereof, or the like. The
dialysis machine can further comprise a front panel having
associated therewith a plurality of connectors comprising a blood
pressure device input, a pulse device input, an EKG device input, a
combination thereof, or the like.
With reference to the drawings, FIG. 1 is a front view of an
interior 100 of a vehicle in accordance with one or more
embodiments of the present invention. While the vehicle can be an
autonomous vehicle, it does not have to be. The vehicle includes a
dashboard 102, a dialysis machine 104 mounted in or on dashboard
102, and a user interface 106 that can be used for programming
dialysis machine 104 and a vehicle navigation system. User
interface 106 can include a keyboard 108, a display screen 110, a
microphone, and quick control buttons 136 for controlling display
screen 110. Display screen 110 can be a shared display screen for
displaying user prompts, inquiries, instructions, and the like
information. Display screen 110 can be split, for example, as a
function of one or more of quick control buttons 136. Navigation
information 112 and dialysis therapy information 114 can
simultaneously be displayed by using a split screen function. One
or more buttons or features can be included to gain access to a
voice-activation system that can be used to input information. The
information can include, for example, vehicle navigation
instructions, dialysis therapy instructions, other information, a
combination thereof, and the like.
Dialysis machine 104 can comprise a blood pump 120, a dialysate
pump 122, a dialyzer 124, a sorbent cartridge 126, an
anti-coagulant injection system 128, a pressure sensor 130, and a
drip chamber 132. One or more of the dialysis machine components
can be provided as a disposable. Many of the dialysis machine
components can be provided together as a disposable kit.
The vehicle in which dialysis machine 104 is mounted can include a
navigation system for which information can be displayed on display
screen 110. In FIG. 1, navigation information 112 is displayed on
right-hand side of display screen 110, and display screen 110 is
configured for a split screen display. The left-hand side of
display screen 110 can display information, user prompts,
inquiries, instructions, and the like, pertaining to a dialysis
therapy to be carried out by dialysis machine 104.
A door, not shown, can be used to encase and protect dialysis
machine 104 within a recess 150 that is provided in dashboard 102.
Access to dialysis machine 104 can be gained, for example, by a
lock on the door, or by a latch, for example, that includes a
handle disposed within a glove box 134.
The dialysate circuit of dialysis machine 104 can include a
to-reservoir line 140 and a from-reservoir line 142 that are in
fluid communication with a remote reservoir (not shown). The remote
reservoir can be disposed, for example, in glove box 134, in a
trunk of the vehicle, in a back seat of the vehicle, in the
passenger seat, mounted elsewhere in the dashboard, or in another
suitable location of the vehicle. The reservoir can be
operationally associated with a heater, a scale, or both. For
example, the reservoir can be disposed on top of a heater and a
scale. Dialysis machine 104 can further include a from-patient
venous catheter line 144 and a to-patient arterial catheter line
146 for connection of dialysis machine 104 to a patient. Venous
catheter line 144 and arterial catheter line 146 can be included in
a disposables kit, for example, in a kit that further includes
dialyzer 124, sorbent cartridge 126, anti-coagulant injection
system 128, drip chamber 132, and interconnecting tubing. Any
number of different disposables kits can be configured to operate
in conjunction with dialysis machine 104, and many are described
below. Different kits can be provided to carry out different
therapies.
Information pertaining to operation of the vehicle can be displayed
in a vehicle operation information display panel 138. The
information can include, for example, speed, rpm, oil temperature,
oil pressure, outside temperature, and the like. According to one
or more embodiments of the present invention, the vehicle
navigation system and dialysis machine 104 can be interfaced such
that a dialysis therapy can be carried out on a patient while the
vehicle transports the patient to a destination.
FIG. 2 is a front view of a vehicle seat 200 in accordance with one
or more embodiments of the present invention. Vehicle seat 200
includes a dialysis machine 204 incorporated therein. Dialysis
machine 204 can be set in, or wholly or partially recessed within,
a recess 250 formed in vehicle seat 200. In the embodiment
depicted, dialysis machine 204 is recessed into the back of vehicle
seat 200, although other positions can be used.
While the vehicle seat can be provided in an autonomous vehicle,
the vehicle does not have to be autonomous. Dialysis machine 204
can be provided with a user interface, and in an exemplary
embodiment, the user interface can comprise a touch screen, for
example, display screen 210 can also be used as a touch screen
input device that can be used for programming dialysis machine 204.
Dialysis machine 204 can be interfaced with a vehicle navigation
system so that a therapy would not be authorized if the vehicle is
expected to arrive at a desired destination before a requested
therapy can be completed. Although not shown, the user interface
can also or instead include a keyboard, a microphone, a joy stick,
a combination thereof, or the like.
Display screen 210 can be controlled, at least in-part, by quick
control buttons 236. Display screen 210 can be a shared display
screen for displaying user prompts, inquiries, instructions, and
the like information. Display screen 210 can be split, for example,
as a function of one or more of quick control buttons 236. Although
only dialysis therapy information 214 is displayed on display
screen 210, in FIG. 2, it is to be understood that navigation
information and dialysis therapy information can simultaneously be
displayed by using a split screen function. One or more buttons or
features can be included to gain access to a voice-activation
system that can be used to input information. The information can
include, for example, vehicle navigation instructions, dialysis
therapy instructions, other information, a combination thereof, and
the like.
Dialysis machine 204 can comprise a blood pump 220, a dialysate
pump 222, a dialyzer 224, a sorbent cartridge 226, an
anti-coagulant injection system 228, a pressure sensor 230, and a
drip chamber 232. One or more of the dialysis machine components
can be provided as a disposable. Many of the dialysis machine
components can be provided together as a disposable kit.
The vehicle in which vehicle seat 200 and dialysis machine 204 are
mounted can include a navigation system for which information can
be displayed on display screen 210, for example, navigation
information can be displayed on a right-hand side of display screen
210 while therapy information can be displayed on the left-hand
side of display screen 210. The information can include user
prompts, inquiries, instructions, warnings, alarm signals, and the
like, pertaining to a dialysis therapy to be carried out, or being
carried out, by dialysis machine 204.
A door, not shown, can be used to encase and protect dialysis
machine 204 within recess 250. Access to dialysis machine 204 can
be gained, for example, by a lock on the door, or by a latch, for
example, that includes a handle. A hinge can be provided spaced
from, but close to, the edge 252 of vehicle seat 200. The hinge can
be provided to hingedly attach the door to recess 250 or elsewhere
to vehicle seat 200.
The dialysate circuit of dialysis machine 204 can include a
to-reservoir line 240 and a from-reservoir line 242 that are in
fluid communication with a reservoir 260. The reservoir can
alternatively be disposed, for example, in a glove box, under
vehicle seat 200, in a trunk of the vehicle, in a back seat of the
vehicle, in a passenger seat of the vehicle, in a cargo hold, or in
another suitable location of the vehicle. The reservoir can be
operationally associated with a heater, a scale, or both. For
example, as shown, a heating and weighing system 270 can be
provided underneath reservoir 260, for heating and weighing the
contents of reservoir 260. A conductivity sensor 272 can also be
provided for measuring the conductivity of dialysate in the
reservoir.
Dialysis machine 204 can further include a from-patient venous
catheter line 244 and a to-patient arterial catheter line 246 for
connection of dialysis machine 204 to a patient. The patient can
sit, for example, in a seat directly behind vehicle seat 200,
during therapy. Venous catheter line 244 and arterial catheter line
246 can be included in a disposables kit, for example, in a kit
that further includes dialyzer 224, sorbent cartridge 226,
anti-coagulant injection system 228, drip chamber 232, and
interconnecting tubing. Any number of different disposables kits
can be configured to operate in conjunction with dialysis machine
204, and many are described below. Different kits can be provided
to carry out different therapies.
FIG. 3 is a flow chart depicting a process for enabling a user to
input a prescribed therapy for dialysis, which is to be completed
while the user is traveling to a destination. Initially, a user can
input a prescription therapy to be carried out, and a destination.
Although either the therapy or the destination can be input first,
FIG. 3 depicts inputting the prescription therapy as a first step
300, followed by a step 302 for inputting a destination. The
therapy and/or destination can be input using voice activation, a
keyboard, a touch screen, a joystick, a combination thereof, or the
like. The vehicle navigation system can be provided with a
processor and a global positioning system (GPS), which together can
be used to calculate an arrival time, as depicted in step 304.
During travel, adjustments to the calculated arrival time can be
made and one or more revised arrival times can be displayed.
As depicted in step 306, the processor can determine, based on the
inputted prescription therapy and the calculated arrival time,
whether the requested therapy can be completed before the arrival
time. If so, a dialysis machine display screen can be used to
display a message such as "Press START to proceed with therapy," as
depicted in step 308. If the processor determines that the
requested therapy cannot be completed before the arrival time, in
step 306, then the display can be powered to show a message such as
"Insufficient time until arrival to complete therapy," as depicted
in step 310. If the processor, or an associated data store, memory,
or other source of data, indicates that optional therapies are
available that can be completed before the calculated arrival time,
the processor can power the display to show a message such as "Show
therapies that can be completed before arrival time?", as depicted
in step 312. If there are alternative therapies available, the
system can be configured to display the different options and the
user can be prompted to select one of the alternative therapies, or
cancel programming. If the user does not want to see a listing of
alternative therapies that are available, the user can input "No"
in response to the query of step 314, and in response, the system
can be configured to display a message such as "Press GO to proceed
to destination," as depicted in step 316.
If alternative therapies are available and the user wants to see
them, the user can input a YES command in response to the query of
step 314 and the processor can calculate and display the
alternative therapies that can be completed before the arrival
time. Calculating the therapies is depicted in step 318 and
displaying the therapies is depicted in step 320. Once the
alternative therapies are displayed, the user can be prompted to
select one of the alternative therapies, and the selection can be
input in a step 322. Once an alternative therapy is selected, the
display can be powered to show a message such as "Press START to
proceed with therapy," as depicted in step 324.
FIG. 4 is a flow chart depicting a process for enabling a user to
input a prescribed therapy for dialysis, to be completed while
traveling to a destination. In the process depicted in FIG. 4, a
vehicle information system is interfaced with a dialysis machine
control system and a processor can be used to determine whether
there is sufficient fuel, battery power, other energy source, or a
combination thereof, to operate the vehicle for the length of time
that would be required to complete the requested dialysis therapy.
While many energy sources can be used, the sources are exemplified
as fuel (or power) in FIG. 4. As depicted in FIG. 4, a prescription
for a dialysis therapy can be input into a processor, as shown in
step 400. The processor can then calculate, based on the amount of
available fuel, battery power, other energy source, or combination
thereof, whether the vehicle has sufficient fuel, battery power,
energy sources, or the like, to operate for the necessary length of
time. The calculating is depicted in step 402. Once the fuel and/or
battery power has been compared to the amount needed to complete
the requested prescription therapy, the processor then can respond
to the query shown in step 404, that is, whether the vehicle has
sufficient fuel and/or battery power. If there is sufficient fuel
and/or battery power, the processor can send a signal to display a
message such as, "Press START to proceed with therapy," as depicted
in step 406.
If the processor determines that the requested therapy cannot be
completed based on the available fuel or power, in step 404, then
the display can be powered to show a message such as "Insufficient
fuel (or power) to complete therapy," as depicted in step 408. If
the processor, or an associated data store, memory, or other source
of data, indicates that optional therapies are available that can
be completed with the available fuel or power, the processor can
power the display to show a message such as "Show therapies that
can be completed with available fuel (or power)?", as depicted in
step 410. If there are alternative therapies available, the system
can be configured to display the different options and the user can
be prompted to select one of the alternative therapies, or cancel
programming. If the user does not want to see a listing of
alternative therapies that are available, the user can input "No"
in response to the query of step 412, and in response, the system
can be configured to display a message such as "Therapy canceled,"
as depicted in step 414.
If alternative therapies are available and the user wants to see
them, the user can input a YES command in response to the query of
step 412 and the processor can calculate and display the
alternative therapies that can be completed based on the available
fuel or power. Calculating the therapies is depicted in step 416
and displaying the therapies is depicted in step 418. Once the
alternative therapies are displayed, the user can be prompted to
select one of the alternative therapies, and the selection can be
input in a step 420. Once an alternative therapy is selected, the
display can be powered to show a message such as "Press START to
proceed with therapy," as depicted in step 422.
FIG. 5 is a flow chart depicting a process for enabling one or more
dialysis machine and/or vehicle actions in response to an alarm
signal. As described in greater detail below, the dialysis machine
incorporated in the vehicle can be provided with an alarm system
configured to generate one or more alarm signals indicative of one
or more, respective, alarm states. As with conventional dialysis
machines, the dialysis machine can be provided with sensors for
detecting leaks, occlusions, air bubbles, loss of pressure,
disconnect, elevated pressure, blood pulse, electrocardiogram, or
other conditions and parameters. In many cases, a low level alarm
signal can be generated for conditions that can be easily corrected
by the user. In some cases, however, a more serious condition can
trigger an emergency state alarm signal, for example, indicative of
a grave situation needing immediate attention and which the user
may not be able to correct. An exemplary condition that might
trigger an emergency state alarm signal would be a lack of pulse, a
lack of heart beat, a lack of arterial pressure, or a vehicle
collision. As shown in FIG. 5, the alarm system can be programmed
to receive an alarm signal in step 500, and determine whether the
alarm signal is an emergency state signal, as depicted in step 502.
If the alarm signal is an emergency state alarm signal, the alarm
system can be configured to calculate the nearest emergency care
center, as depicted in FIG. 504, and navigate the vehicle to the
nearest emergency care center, as depicted in step 506. The alarm
system can display a message such as "Proceeding to nearest
emergency care center," as depicted in step 508. The alarm system
can further be configured to provide additional information, for
example, by displaying the name, address, and phone number of the
nearest emergency care center to which the vehicle is being
navigated, as depicted is step 510. The alarm system can be
configured to automatically call a help hotline or 911.
If, the alarm system determines that the alarm signal is not for an
emergency state, in step 502, then the alarm system can be
configured to stop the blood pump as depicted in step 512 and
display a message such as "Check connections, check for occlusion,
check for air bubbles," as depicted in step 514. The user is thus
prompted to take corrective action as depicted in step 516, for
example, to reestablish a connection, to remove an air bubble, to
adjust the position of a catheter in a vein or artery, or the like.
After taking the corrective action, the user can then enter a
"Proceed" command and the alarm system can then test for the
condition that caused the low level alarm signal. Testing for the
condition is depicted in step 518. If the condition is corrected,
as queried in step 520, then the alarm system can be reset as
depicted in step 522. If, however, the condition is not corrected
in response to the user's corrective actions, then the system can
be configured to again display a message such as "Check
connections, check for occlusion, check for air bubbles," as
depicted in step 514, and the corrective action sequence can be
repeated. If, after a predefined number of attempts, the corrective
actions of the user do not correct the alarm condition, the user
may be prompted to proceed to the nearest emergency care
center.
FIGS. 6-19 show a variety of disposable kits, machines, machine and
system components, fluid flow paths, and related features that can
be included in the vehicles and used in the methods of the present
invention. Other components, machines, systems, and methods that
can be used in or a part of the present invention include those
described in U.S. Patent Application Publication No. US
2011/0315611 A1 to Fulkerson et al., and US 2010/0022937 A1 to
Bedingfield et al., which are incorporated herein in their
entireties by reference. Moreover, other dialysis components,
machines, systems, and methods that can be used in or a part of the
present invention include those described in U.S. Pat. No.
4,353,368 to Slovak et al., which is incorporated herein in its
entirety by reference. Furthermore, dialysis components, machines,
systems, and methods related to peritoneal dialysis and which can
be used in or as a part of the present invention include those
described in U.S. Pat. No. 6,129,699 to Haight et al., U.S. Pat.
No. 6,234,992 B1 to Haight et al., U.S. Pat. No. 6,284,139 B1 to
Piccirillo, which are incorporated herein in their entireties by
reference. Also, components, machines, systems, and methods for the
autonomous control of vehicles, which can be used in or a part of
the present invention include those described in U.S. Patent
Application Publications Nos. US 2001/0055063 A1 to Nagai et al.,
US 2012/0316725 A1 to Trepagnier et al., US 2012/0101680 A1 to
Trepagnier et al., US 2012/0035788 A1 to Trepagnier et al., US
2010/0106356 A1 to Trepagnier et al., US 2007/0219720 A1 to
Trepagnier et al., and US 2012/0179321 A1 to Biber et al., which
are incorporated herein in their entireties by reference.
FIG. 6 is a functional block diagram showing an embodiment of an
ultrafiltration treatment system 2800 that can be used in a vehicle
of the present invention. As shown in FIG. 6, blood from a patient
is drawn into blood inlet tubing 2801 by a pump, such as a
peristaltic blood pump, 2802 that forces the blood into a
hemofilter cartridge 2804 via blood inlet port 2803. Inlet and
outlet pressure transducers 2805, 2806 are connected in-line just
before and after the blood pump 2802. The hemofilter 2804 comprises
a semi-permeable membrane that allows excess fluid to be
ultrafiltrated from the blood passing therethrough, by convection.
Ultrafiltered blood is further pumped out of the hemofilter 2804
through blood outlet port 2807 into blood outlet tubing 2808 for
infusion back to into the patient. Regulators, such as clamps,
2809, 2810 are used in tubing 2801 and 2808 to regulate fluid flow
therethrough.
A pressure transducer 2811 is connected near the blood outlet port
2807 followed by an air bubble detector 2812 downstream from the
pressure transducer 2811. An ultrafiltrate pump, such as a
peristaltic pump, 2813 draws the ultrafiltrate waste from the
hemofilter 2804 via UF (ultrafiltrate) outlet port 2814 and into
the UF outlet tubing 2815. A pressure transducer 2816 and a blood
leak detector 2817 are transposed into the UF outlet tubing 2815.
Ultrafiltrate waste is finally pumped into a waste collection
reservoir 2818 such as a flask or soft bag, attached to the leg of
an ambulatory patient and equipped with a drain port to allow
intermittent emptying. The amount of ultrafiltrate waste generated
can be monitored using any measurement technique, including a scale
2819 or flow meter. The microcontroller 2820 monitors and manages
the functioning of the blood and UF pumps, pressure sensors as well
as air and blood leak detectors. Standard luer connections such as
luer slips and luer locks are used for connecting tubing to the
pumps, the hemofilter and to the patient.
Another blood and dialysate circuit capable of being implemented or
used in the embodiments of the dialysis systems is shown in FIG. 7.
FIG. 7 depicts the fluidic circuit for an extracorporeal blood
processing system 2900, used for conducting hemodialysis and
hemofiltration. In one embodiment of the present invention, the
system 2900 is implemented as a portable dialysis system, which may
be used by a patient for conducting dialysis at home. The
hemodialysis system comprises two circuits--a Blood Circuit 2901
and a Dialysate Circuit 2902. Blood treatment during dialysis
involves extracorporeal circulation through an exchanger having a
semi permeable membrane--the hemodialyser or dialyzer 2903. The
patient's blood is circulated in the blood circuit 2901 on one side
of the membrane (dialyzer) 2903 and the dialysate, comprising the
main electrolytes of the blood in concentrations prescribed by a
physician, is circulated on the other side in the dialysate circuit
2902. The circulation of dialysate fluid thus provides for the
regulation and adjustment of the electrolytic concentration in
blood.
The line 2904 from the patient, which transports impure blood to
the dialyzer 2903 in the blood circuit 2901 is provided with an
occlusion detector 2905 which is generally linked to a visual or
audible alarm to signal any obstruction to the blood flow. In order
to prevent coagulation of blood, delivery means 2906, such as a
pump, syringe, or any other injection device, for injecting an
anticoagulant--such as heparin, into blood is also provided. A
peristaltic pump 2907 is also provided to ensure flow of blood in
the normal (desired) direction.
A pressure sensor 2908 is provided at the inlet where impure blood
enters the dialyzer 2903. Other pressure sensors 2909, 2910, 2911
and 2912 are provided at various positions in the hemodialysis
system to track, and maintain, fluid pressure at desired levels at
specific points within the respective circuits.
At the point where used dialysate fluid from the dialyzer 2903
enters the dialysate circuit 2902, a blood leak sensor 2913 is
provided to sense and warn of any leakage of blood cells into the
dialysate circuit. A pair of bypass valves 2914 is also provided at
the beginning and end points of the dialysate circuit, so that
under conditions of start up, or other as deemed necessary by the
machine state or operator, the dialyzer can be bypassed from the
dialysate fluid flow, yet the dialysate fluid flow can still be
maintained, i.e. for flushing or priming operations. Another valve
2915 is provided just before a priming/drain port 2916. The port
2916 is used for initially filling the circuit with a dialysate
solution, and to remove used dialysate fluid after, and in some
instances during, dialysis. During dialysis, valve 2915 may be used
to replace portions of used dialysate with high concentrations of,
for instance, sodium with replenishment fluid of appropriate
concentration so that overall component concentration of the
dialysate is maintained at a desired level.
The dialysate circuit is provided with two peristaltic pumps 2917
and 2918. Pump 2917 is used for pumping dialysate fluid to the
drain or waste container, as well as for pumping regenerated
dialysate into the dialyzer 2903. Pump 2918 is used for pumping out
spent dialysate from the dialyzer 2903, maintaining fluid pressure
through the sorbent 2919, and pumping in dialysis fluid from port
2916 to fill the system or maintain component concentration in the
dialysate.
A sorbent cartridge 2919 is provided in the dialysate circuit 2902.
The sorbent cartridge 2919 contains several layers of materials,
each having a role in removing impurities, such as urea and
creatinine. The combination of these layered materials allows water
suitable for drinking to be charged into the system for use as
dialysate fluid. It also allows closed loop dialysis. That is, the
sorbent cartridge 2919 enables regeneration of fresh dialysate from
the spent dialysate coming from the dialyzer 2903. For the fresh
dialysate fluid, a lined container or reservoir 2920 of a suitable
capacity such as 0.5, 1, 5, 8 or 10 liters is provided.
Depending upon patient requirements and based on a physician's
prescription, desired quantities of an infusate solution 2921 can
be added to the dialysis fluid. Infusate 2921 is a solution
containing minerals and/or glucose that help replenish minerals
like potassium and calcium in the dialysate fluid at levels after
undesired removal by the sorbent. A peristaltic pump 2922 is
provided to pump the desired amount of infusate solution 2921 to
the container 2920. Alternatively, the infusate solution 2921 can
be pumped into the outflow line from reservoir 2920. A camera 2923
may optionally be provided to monitor the changing liquid level of
the infusate solution as a safety check warning of infusate flow
failure and/or function as a bar code sensor to scan bar codes
associated with additives to be used in a dialysis procedure.
A heater 2924 is provided to maintain the temperature of dialysate
fluid in the container 2920 at the required level. The temperature
of the dialysate fluid can be sensed by the temperature sensor 2925
located just prior to the fluids entry in to the dialyzer 2903. The
container 2920 is also equipped with a scale 2926 for keeping track
of the weight, and therefore volume, of the fluid in the container
2920, and a conductivity sensor 2927, which determines and monitors
the conductivity of the dialysate fluid. The conductivity sensor
2927 provides an indication of the level of sodium in the
dialysate.
A medical port 2929 is provided before blood from the patient
enters the system for dialysis. Another medical port 2930 is
provided before clean blood from the dialyzer 2903 is returned to
the patient. An air (or bubble) sensor 2931 and a pinch clamp 2932
are employed in the circuit to detect and prevent any air, gas or
gas bubbles from being returned to the patient.
Priming set(s) 2933 is/are attached to the dialysis system 2900
that help prepare the system by filling the blood circuit 2901 with
sterile saline before it is used for dialysis. Priming set(s) may
consist of short segments of tubing with IV bag spikes or IV
needles or a combination of both pre-attached.
It should be appreciated that, while certain of the aforementioned
embodiments disclose the incorporation and use of a port that
receives an injection or administration of an anticoagulant,
thereby creating an air-blood interface, such a port can be
eliminated if the device can operate with minimal risk of blood
clotting at ports of entry and exit. As further discussed below,
the manifold design, particularly with respect to the internal
design of the manifold ports, minimizes the risk of blood clotting,
thereby creating the option of eliminating air-blood interfaces for
receiving an injection or administration of an anticoagulant.
One of ordinary skill in the art would infer from the above
discussion that the exemplary fluidic circuits for a hemodialysis
and/or hemofiltration system are complex. If implemented in a
conventional manner, the system would manifest as a mesh of tubing
and would be too complicated for a home dialysis user to configure
and use. Therefore, in order to make the system simple and easy to
use at home by a patient, embodiments of the present invention
implement the fluidic circuits in the form of a compact manifold in
which most components of the fluidic circuit are integrated into a
single piece of molded plastic or multiple pieces of molded plastic
that are configured to connect together to form a single operative
manifold structure.
FIG. 8 is a diagram detailing the fluidic circuit for the compact
manifold according to one embodiment of the present invention. The
fluidic circuit comprises four pump tube segments 3301, 3302, 3303
and 3304 in pressure communication with pumps within the top
controller unit and pump shoes in the top controller unit door. It
further comprises five pressure membranes in pressure communication
with pressure sensors 3305, 3306, 3307, 3308 and 3309, and an area
in thermal or optical communication with a temperature sensor 3310.
In the embodiment illustrated in FIG. 8, three pairs of membranes,
shown at 3311, 3312 and 3313, are integrated into the manifold. The
membranes function as valves when they are occluded by a pin,
member or protrusion from the controller unit.
Grouped in this manner the pairs of six one way valves form three
two-way valve assemblies 3311, 3312, and 3313. The two-way valves
provide greater flexibility in controlling the configuration of a
circuit. When conventional two-way valves are used to occlude
portions of a fluid pathway, they are typically configured to
enable two different fluid pathways, one for a first valve state
and one for the second valve state. Certain valve embodiments, as
disclosed below, used in combination with the valve membranes or
pressure points integrated into the manifold, enables more nuanced
control, enabling the creation of four distinctly different fluid
flow paths.
Pump tube segments 3301, 3302, 3303, 3304 are bonded into the
compact manifold. A number of ports are provided in the manifold,
which connect with tubes external to the manifold to allow the flow
of various fluids in and out of the manifold. These ports are
connected to various tubes in the blood purification system for
carrying fluids as follows:
Port A 3315-blood to the dialyzer 430;
Port B 3316-dialyzer output (used dialysate);
Port C 3317-blood from the patient;
Port D 3318-heparin for mixing in the blood;
Port E 3319-reservoir output (fresh dialysate);
Port F 3320-dialyzer input (fresh dialysate);
Port G 3321-dialyzer output (blood);
Port H 3322-patient return (clean blood);
Port J 3323-connects to prime and drain line;
Port K 3324-reservoir infusate input;
Port M 3325-infusate in from infusate reservoir; and
Port N 3326-dialysate flow into sorbent.
In one embodiment, a tube segment, formed as a pathway molded into
the manifold structure 3300, connects the fluid flow of heparin,
entering via Port D 3318, to the fluid flow of blood, entering via
Port C 3317. The combined heparin and blood flow through port
3317a, via pump segment 3301, and into port 3317b of the manifold
3300. A pressure transducer is in physical communication with a
membrane 3305, formed in the manifold structure 3300, which, in
turn, passes the blood and heparin fluid through Port A 3315. Fluid
flow out of the manifold 3300 at Port A 3315 passes through
dialyzer 3330, which is external to the manifold 3300. The dialyzed
blood passes back into the manifold 3300 through Port G 3321 and
into a segment 3307, formed as a pathway molded into the manifold
structure 3300, that is in physical communication with pressure
transducer. Fluid then passes from the segment through Port H 3322
and into a patient return line.
Separately, dialysis fluid enters the manifold 3300 from a
reservoir via Port E 3319. Fluid in the reservoir has infusate in
it, which first enters the manifold 3300 via Port M 3325, passes
through a segment, formed as a pathway molded into the manifold
structure 3300, through another port 3325a, through a segment 3302
in communication with a pump, and back into the manifold 400 via
port 425b. The infusate passes through a segment, formed as a
pathway molded into the manifold structure 3300, and out the
manifold 3300 at Port K 3324, where it passes into the reservoir.
The dialysis fluid which entered the manifold via Port E 3319,
passes through a segment, formed as a pathway molded into the
manifold structure 3300, through another port 3319a, through a
segment 3303 in communication with a pump, and back into the
manifold 3300 via port 3319b.
The dialysate fluid passes into a segment, formed as a pathway
molded into the manifold structure 3300, which is in physical
communication with a pair of valves 3311. A segment, formed as a
pathway molded into the manifold structure 3300, passes the
dialysate fluid to another pair of valves 3313. The segment is in
physical communication with pressure transducers 3308 and optional
temperature sensor 3310. The dialysate fluid passes out of the
manifold 3300 through Port F 3320, and into a line that passes into
the dialyzer 3330.
A line out of the dialyzer 3330 passes fluid back into the manifold
3300 through Port B 3316 and into a segment, formed as a pathway
molded into the manifold structure 3300, that is in physical
communication with a first pair of valves 3311, a second pair of
valves 3312, and a pressure transducer 3306. The used dialysate
fluid passes out of the manifold 3300 through port 3326b, through
segment 3304 in communication with a pump, and back into the
manifold via port 3326a. A segment in fluid communication with port
3326a is in physical communication with pressure transducer 3309
and passes fluid through Port N 3326 and to a sorbent regeneration
system.
The ports are designed for circuit tubing (e.g. 0.268'' by 0.175''
tubing) or for anticoagulant and infusate tubing (e.g. 0.161'' by
0.135''). Preferably, the tubing ports are bonded with a suitable
solvent. It should be appreciated that the valves shown in FIG. 8,
specifically, valves 3311, 3312, and, 3313, can be positioned in a
different locations within the manifold. Referring to FIG. 19,
valve 8611 (valve 3311 in FIG. 8) can be positioned in the central
vertical portion 8650 of the manifold 8600 adjacent to and parallel
to valve 8612 (valve 3312 in FIG. 8). Also on the central vertical
portion 8650 of the manifold 8600, which connects the top
horizontal portion 8630 and bottom horizontal portion 8640
together, is valve 8613 (valve 3313 in FIG. 8). Valve 8613 is on
the bottom portion of the central vertical portion 8650 and
positioned substantially below and centered between valves 8611,
8612.
The 2-way valves can operate by having valve actuators, which are
mounted on the instrument, compress an elastomeric diaphragm over a
volcano seal to prevent dialysate flow through its respective
pathway, as described in further detail below. The volcano seal
opening is approximately 0.190'' diameter to match the channel
geometry. The cross-sectional pathway through the interior of the
valve is at least equivalent to 0.190'' diameter when valves are
open. When the valve is in the closed position the valve actuator
and elastomeric diaphragm consume most of the fluid path space
around the volcano seal minimizing the potential for air
entrapment. There are raised plastic features on the mid-body that
minimize dead space within the fluid path as well as help prevent
diaphragm from collapsing around the center fluid path under
negative pressure conditions. The elastomeric diaphragm has an
o-ring feature around its perimeter that fits into a groove on the
mid-body surface. The o-ring is compressed between the mid-body and
back cover to form a fluid tight seal. The design provides for
approximately 30% compression on the o-ring. The 2-way valves
control the direction of dialysate flow through the manifold.
The manifold contains structures that allow for fluid pressure
monitoring across diaphragms through the use of sensors in the
instrument. Fluid is allowed to flow from channels on the front
cover side of the mid-body through inlet and outlet holes
underneath the diaphragm on the back cover side. The
cross-sectional pathway through the interior of the pressure
sensing structure is at least equivalent to 0.190''. The interior
pathway is designed to minimize air entrapment while providing
adequate fluid contact with the diaphragm. The elastomeric
diaphragm has an o-ring feature around its perimeter that fits into
a groove on the mid-body surface. The o-ring is compressed between
the mid-body and back cover to form a fluid tight seal. The design
provides for a 30% compression on the o-ring.
The valves and diaphragms can be made from a variety of different
materials and by different processes. The elastomeric components
can be made from silicone, a variety of thermoplastic elastomers, a
combination thereof, or the like. Two shot molding may be used to
attach the valves and diaphragms to the back cover. Two shot
molding of valves and diaphragms would remove the need to
individually assemble these parts into the manifold therefore
reducing labor costs and improve quality of the manifold
assembly.
Pumping components in the manifold design have been defined as PVC
header tubing. These headers combined with rotary peristaltic
pumping system of the instrument provide the flow of blood,
dialysate, and infusate. The circuit tubing material for dialysate,
infusate, and anticoagulant is preferably kink resistant, such as
the tubing referred to as Colorite, Unichem PTN 780, (80 A
durometer) extruded by Natvar, all TEKNIplex companies. The tubing
dimensions for the dialysate lines ranges from
0.268''.times.0.189'' to 0.268''.times.0.175
Flow within the manifold can be measured by a thermal flow meter.
FIG. 9 illustrates a thermal fluid flow measurement device 5601
installed with the manifold 5602 in the dialysis machine 5610. The
manifold 5602 has fluid flow paths or tubing circuit 5603 embedded
within. The dialysis machine 5610 has a front door 5620 which can
be opened to install the disposable manifold 5602. Further, the
front door 5620 is equipped with pins 5621 that, when the door 5620
is closed, can make contact with electrical points on the manifold
5602 to read information or provide electrical input.
The thermal fluid flow measurement device 5601 can further comprise
a series of contacts 5611, 5612 and 5613. Operationally, as fluid
(such as blood, dialysate or other fluids) flows during dialysis
through the fluid flow path 5603, it passes the first contact 5611
which is embedded in the plastic pathway. The contact 5611 makes
electrical contact with an electrical source, which can be a pin
5621 on the machine front door 5620. The electrical source or pin
is controlled by a controller in the dialysis machine 5610. The
electrical source provides an electrical stimulus to the contact
5611, which acts to micro heat the contact based on a sine-wave
method.
The micro heating process effectuates a temperature increase of
between 0.1 and 1.0 degrees Celsius in the fluid being measured.
This is effectuated by means of micro heaters located at the first
contact 5611, which produce heat on receiving the electrical
stimulus. Micro heaters for the thermal fluid flow measurement
device of the present invention can be manufactured using any
design suitable for the application. In one embodiment for example,
the micro heater is made up of 10 turns of 30 g copper wire wound
around a pin located at the first contact position 5611.
As the contact 5611 gets micro-heated, the resulting thermal energy
acts to create a thermal wave, which propagates downstream from the
first contact 5611. A plurality of contacts, which can be two in
number--5612 and 5613--are located downstream from the first
contact 5611, and are used to measure the time of flight of the
thermal wave. The measured phase of the wave is then compared with
the initial wave generated by the first contact 5611. The phase
difference thus determined provides an indication of the flow
rate.
FIG. 10 is a block diagram of a system 5800 for detecting a
patient's disconnection from an extracorporeal blood circuit.
System 5800 comprises an incoming arterial blood circuit 5802, a
dialyzer 5804, a dialysate circuit 5806, a patient pulse pressure
transducer 5808, a patient cardiac signal generator 5815 for
reference, a disconnect monitor 5820, a controller 5825 and a
return venous blood circuit 5810. In various embodiments of the
present invention, blood drawn from a patient is passed through the
dialyzer 5804 via the arterial blood circuit 5802 and cleansed
blood from the dialyzer 5804 is returned to the patient via the
venous blood circuit 5810. Contaminated dialysate expelled from the
dialyzer 104 is purified or regenerated within the dialysate
circuit 5806 and is pumped back into the dialyzer 5804. The
cleansed blood can be returned to a patient's body via a
transdermal needle or a luer connected catheter. Blood flow rates
in the return venous blood circuit 5810 are typically in the range
of 300-400 ml/min. It should be appreciated that any suitable
dialysis circuit can be deployed.
The pressure transducer 5808 measures the pressure pulse of a
patient undergoing the blood processing treatment routine and
communicates the pulse pressure substantially continuously to the
disconnect monitor 5820. In one embodiment the transducer 5808 is
an invasive or non-invasive venous pressure sensor located anywhere
in the dialysis blood line (the incoming arterial blood circuit
5802 or the return venous blood circuit 5810). In another
embodiment, the transducer 5808 is an invasive or non-invasive
venous pressure sensor located specifically in a dialysis blood
line between the dialyzer 5804 and the patient, that is, in the
return venous blood circuit 5810. A non-invasive air bubble
detector and/or pinch valve (not shown) are optionally located
between the transducer 5808 and the luer connection to the patient.
The pressure transducer 5808 can be located in close proximity to
the needle or catheter inserted in the patient's body for providing
vascular access corresponding to the return venous blood circuit
5810. The pressure transducer 5808 is located in close proximity to
the needle or catheter in order to preserve waveform fidelity. In
other embodiments, the pressure transducer 5808 may be connected
anywhere in the return venous blood circuit 5810. In an embodiment
of the present invention, the pressure signal produced by the
pressure transducer 5808 is an alternating current (AC) signal
which is not an accurate measure of vascular pressure. Hence, the
pressure transducer 5808 is not a high accuracy transducer.
The reference signal generator 5815 communicates the patient's
cardiac signal substantially continuously to the disconnect monitor
5820 for reference. The reference cardiac signal can be obtained
from a plethysmograph connected to the same body part (such as an
arm) to which the needle or catheter supplying processed blood to a
patient is connected. In some cases the reference cardiac signal is
obtained from a finger pulse sensor/oximeter. In various other
embodiments of the present invention, the reference cardiac signal
may be obtained an electro-cardiogram (ECG) signal, a real time
blood pressure signal, stethoscope, arterial pressure signal from
the blood withdrawal line, oximeter pulse signal, alternate site
plethysmograph signal, transmissive and/or reflective
plethysmograph signals, acoustic cardiac signals, wrist pulse or
from any other cardiac signal source known to persons of ordinary
skill in the art.
The disconnect monitor 5820 detects a disruption in the return
venous blood circuit 5810 caused by the disconnection of a needle
or catheter, from the body of a patient undergoing blood processing
treatment. To detect a disconnection, the monitor 5820 processes
the patient pulse pressure transducer and cardiac reference
signals. Persons of ordinary skill in the art would appreciate that
such disconnection may be caused by the needle or catheter being
pulled out of the patient's body due to any reason such as a sudden
movement of the patient. The disconnect monitor 5808 can be of a
type known to those skilled in the art. Controller 5825 is any
microprocessor known to persons of ordinary skill in the art. The
function of the controller 5825 is to receive processed inputs from
the monitor 5820 and accordingly trigger appropriate actions, when
required.
Persons of ordinary skill in the art should appreciate that the
pressure transducer and reference signals are communicated to the
disconnect monitor 5820 through transmitters incorporated into the
reference signal generator and pressure transducer. The transmitter
can enable a wired or wireless communication to a corresponding
receiver. Similarly, data from the disconnect monitor 5820 is
communicated to the controller 5825 through wired or wireless
connection. In one embodiment, such signal communication is enabled
using an appropriate wired or wireless public and/or private
network such as LAN, WAN, MAN, Bluetooth networks, and/or the
Internet. Also, the disconnect monitor 5820 and controller 5825 can
be located in proximity to each other and to the pressure
transducer 5808 and the cardiac reference signal generator 5815. In
an alternate embodiment, both or either of the disconnect monitor
5820 and the controller 5825 are/is located remotely from each
other and/or from the rest of the components of the system
5800.
FIG. 11 is a flow diagram showing exemplary steps of a method of
ascertaining patient's disconnection from an extracorporeal blood
circuit, in accordance with an embodiment of the present invention.
In operation, dialysis system software, comprising a plurality of
instructions and executing on a processor, prompts a patient to
first attach a cardiac signal generator (such as a finger pulse
oximeter) to obtain 6005 a reference signal. At this point the
patient may or may not be connected to a dialysis system.
Thereafter or concurrent to capturing the cardiac reference signal,
the dialysis system software, comprising a plurality of
instructions and executing on a processor, prompts a patient to
connect to the system 5800 of FIG. 10 as a result of which patient
pulse pressure transducer signal is also obtained 6010. Next, a
cross correlation processor attempts to correlate 6015 the
reference and transducer signals. If no correlation can be achieved
at start-up, in one embodiment, the patient is prompted to turn off
6020 all or certain components or, in another embodiment, the
controller 5825 of the system 5800 of FIG. 10 does this
automatically to lower noise level. For example, shutting off the
pumps of the dialysis system can lower the noise and make it easier
to capture and correlate the two signals. In another embodiment, a
cross-correlation is attempted before noise-generating system
components, such as pumps, are turned on. Thus, lock down of a
correlation is attempted before complete system start-up can be
completed. If no correlation is locked down, an alarm can be
triggered, indicating the patient dialysis system may have an
anomaly.
If a correlation is obtained, however, then that correlation is
substantially continually monitored 6025. If there is any deviation
in that correlation, an alarm is triggered 6030, indicating a
possible leak or, optionally, the system is shut down (completely
or partially) and an attempt to re-establish the correlated signal
is attempted again. If the nature of the correlation changes or
deviates beyond or within a predefined threshold, certain system
components, such as pumps, can be shut down and the cross
correlation processor attempts to re-establish the correlation. If
the correlation cannot be re-established, then an alarm is
triggered. In some cases, if the nature of the correlation changes
or deviates beyond or outside the range of a predefined threshold,
certain system components, such as pumps, can be shut down and an
alarm is immediately triggered, before any additional attempt to
re-establish the correlation.
This approach to monitoring disconnection provides certain distinct
improvements over the prior art. First, unlike the prior art, the
present system can be responsive if the needle is just barely
pulled out or if it is removed and pulled quite some distance from
the insertion site. Second, the system does not need any extra
apparatus placed at the insertion site, such as a moisture pad.
Third, by cross correlating the patients' own cardiac signal, the
false negatives are greatly diminished. Fourth, the combination of
pressure pulse sensing and cross correlation renders the system
capable of detecting low signal to noise ratio signals. Fifth,
continuously monitoring the cross correlation status enables the
system to detect small signal deviations which could potentially
indicate a disconnection. Therefore, an apparatus and method for
detection of disconnection in an extracorporeal blood circuit being
used for any blood processing treatment routine, is provided by the
present invention.
Central Venous Pressure (CVP) can be measured with a remote sensor
inside the hemofiltration machine. Referring to FIG. 12, an
exemplary blood circuit 6400 with the provision of CVP measurement
is illustrated. As blood enters into the circuit 6400 from the
patient, an anticoagulant is injected into the blood using the
syringe 6401, to prevent coagulation. A pressure sensor, PBIP 6410
is provided, which is used for the measurement of central venous
pressure. A blood pump 6420 forces the blood from the patient into
the dialyzer 6430. Two other pressure sensors, PBI 6411 and PBO
6412, are provided at the inlet and the outlet respectively of the
dialyzer 6430. The pressure sensors PBI 6411 and PBO 6412 help keep
track of and maintain fluid pressure at vantage points in the
hemodialysis system. A pair of bypass valves B 6413 and A 6414 is
also provided with the dialyzer, which ensures that fluid flow is
in the desired direction in the closed loop dialysis circuit. The
user can remove air at the port 6417 if air bubbles have been
detected by sensor 6418. A blood temperature sensor 6416 is
provided prior to the air elimination port 6417. An AIL/PAD sensor
6418 and a pinch valve 6419 are employed in the circuit to ensure a
smooth and unobstructed flow of clean blood to the patient. A
priming set 6421 is pre-attached to the haemodialysis system that
helps prepare the system before it is used for dialysis.
For taking CVP measurement, blood flow in the circuit 6400 is
stopped by stopping the blood pump 6420. At this point, the
pressure in the catheter used for accessing blood (not shown) will
equilibrate, and the pressure measured at pressure sensor PBIP 6410
in the hemofiltration machine will be equal to the pressure at the
catheter tip. This measured pressure (CVP) is then used to regulate
the rate of ultrafiltration and the volume of fluid removed from
the patient.
Thus, operationally, the system modifies a conventional dialysis
system such that ultrafiltration is conducted at a rate preset by
the physician. Periodically, the blood flow is stopped and the
average CVP is measured, using one of the various measurement
methods described above. In one embodiment, a safety mode is
provided, wherein if CVP drops below a preset limit, hemofiltration
is discontinued and an alarm sounded.
In another application, a hypervolemic patient such as a patient
with Congestive Heart Failure (CHF) may be given ultrafiltration to
remove fluids. It is known in the art that while the
ultrafiltration process removes fluid from the blood, the fluid
that is intended to be removed is located in the interstitial
spaces. Further, the rate of fluid flow from the interstitial
spaces into the blood is unknown. A physician can pre-set the total
amount of fluid he wants removed--typically computed from patient
weight, and the minimal average CVP allowed. The system then
removes fluid at the maximum rate that automatically maintains the
desired CVP. That is, the system automatically balances the fluid
removal rate with the fluid flow rate from the interstitial spaces
into the blood.
It should be appreciated that normal CVP levels is between 2 and 6
mmHg Elevated CVP is indicative of over hydration, while decreased
CVP indicates hypovolemia. A patient may begin an ultrafiltration
session with a CVP above normal, e.g. 7-8 mmHg, and end the session
at a final CVP target of 3 mmHg through, for example, a 6 hour
treatment session. However, if midway through the treatment
session, CVP has fallen more than 50% of the desired drop, while
the fluid removed has only reached 50% of the final target for
removal, the system can be reprogrammed to reduce the goal for
fluid removal or reduce the rate of fluid removal. Other actions
can be taken based on more complicated algorithms. The net result
is that hypovolemia is avoided by monitoring the rate and actual
value of CVP. It should be appreciated that this approach may also
be useful in controlling fluid removal rates not only during
hemofiltration, but for all types of renal replacement
therapies.
FIG. 13 shows an exploded view of the extracorporeal blood
processing system 6900 configured to operate in hemodialysis
mode.
Blood circuit 6920 comprises a peristaltic blood pump 6921 that
draws a patient's arterial impure blood along the tube 6901 and
pumps the blood through dialyzer 6905. A syringe device 6907
injects an anticoagulant, such as heparin, into the drawn impure
blood stream. Pressure sensor 6908 is placed at the inlet of the
blood pump 6921 while pressure sensors 6909 and 6911 are placed
upstream and downstream of the dialyzer 6905 to monitor pressure at
these vantage points.
As purified blood flows downstream from the dialyzer 6905 and back
to the patient, a blood temperature sensor 6912 is provided in the
line to keep track of temperature of the purified blood. An air
eliminator 6913 is also provided to remove accumulated gas bubbles
in the clean blood from the dialyzer. A pair of air (bubble)
sensors (or optionally a single sensor) 6914 and a pinch valve 6916
are employed in the circuit to prevent accumulated gas from being
returned to the patient.
The dialysate circuit 6925 comprises two dual-channel pulsatile
dialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 draw spent
dialysate solution from the dialyzer 6905 and the regenerated
dialysate solution from reservoir 6934 respectively. At the point
where used dialysate fluid from the dialyzer 6905 enters the
dialysate circuit 6925, a blood leak sensor 6928 is provided to
sense and prevent any leakage of blood into the dialysate circuit.
Spent dialysate from the outlet of the dialyzer 6905 then passes
through the bypass valve 6929 to reach two-way valve 6930. A
pressure sensor 6931 is placed between the valves 6929 and 6930. An
ultrafiltrate pump 6932 is provided in the dialysate circuit, which
is operated periodically to draw ultrafiltrate waste from the spent
dialysate and store it in an ultrafiltrate bag 6933, which is
emptied periodically.
As mentioned previously, spent dialysate can be regenerated using
sorbent cartridges. The dialysate regenerated by means of sorbent
cartridge 6915 is collected in a reservoir 6934. The reservoir 6934
includes conductivity and ammonia sensors 6961 and 6962
respectively. From the reservoir 6934, regenerated dialysate passes
through flow restrictor 6935 and pressure sensor 6936 to reach a
two-way valve 6937. Depending upon patient requirement, desired
quantities of infusate solution from the reservoir 6950 and/or
concentrate solution from the reservoir 6951 may be added to the
dialysis fluid. Infusate and concentrate are sterile solutions
containing minerals and/or glucose that help maintain minerals like
potassium and calcium in the dialysate fluid at levels prescribed
by the physician. A bypass valve 6941 and a peristaltic pump 6942
are provided to select the desired amount of infusate and/or
concentrate solution and to ensure proper flow of the solution into
the cleansed dialysate emanating from the reservoir 6934.
The dialysate circuit comprises two two-way valves 6930 and 6937.
The valve 6930 directs one stream of spent dialysate to a first
channel of dialysate pump 6926 and another stream of spent
dialysate to a first channel of dialysate pump 6927. Similarly,
valve 6937 directs one stream of regenerated dialysate to a second
channel of dialysate pump 6926 and another stream of regenerated
dialysate to a second channel of dialysate pump 6927.
Streams of spent dialysate from pumps 6926 and 6927 are collected
by two-way valve 6938 while streams of regenerated dialysate from
pumps 6926 and 6927 are collected by two-way valve 6939. The valve
6938 combines the two streams of spent dialysate into a single
stream that is pumped via pressure sensor 6940 and through sorbent
cartridges 6915 where the spent dialysate is cleansed and filtered,
collected in the reservoir 6934. The valve 6939 combines the two
streams of regenerated dialysate into a single stream, which flows
to the two-way valve 6945 through a bypass valve 6947. A pressure
sensor 6943 and a dialysate temperature sensor 6944 are provided on
the dialysate flow stream to the two-way valve 6945.
By reversing the state of two way valves 6930, 6937, 6938 and 6939
the two pumps 6926 and 6927 are reversed in their action of one
withdrawing dialysis fluid from the dialyzer 6905 and the other
supplying dialysis fluid to the dialyzer 6905. Such reversal, when
done periodically over short periods of time relative to the
dialysis session, insures that over the longer period of the entire
dialysis session the dialysate fluid volume pumped into the
dialyzer equals the amount of fluid pumped out and the only total
fluid volume lost by dialysis circuit 6925 is that removed by
ultrafiltrate pump 6932, as discussed above.
In hemodialysis mode, two-way valve 6945 allows the regenerated
dialysate to enter dialyzer 6905 to enable normal hemodialysis of
the patient's blood. One side of valve 6945 is closed leading to
the patient's blood return line. Another two-way valve 6946 acts as
a backup, keeping dialysate form the patient's blood line with both
ports of valve 6946 closed even if valve 6945 leaks or fails.
FIG. 14 shows an alternative embodiment of the fluidic circuits
where the backup two-way valve 6946 is not used. The blood circuit
comprises peristaltic blood pump that draws a patient's arterial
impure blood along tube 7001 and pumps the blood through dialyzer
7005. A syringe or pump 7007 injects an anticoagulant, such as
heparin, into the drawn impure blood stream. Pressure sensor 7008
is placed at the inlet of the blood pump while pressure sensors
7009 and 7011 are placed upstream and downstream of a manifold
segment. Purified blood from the dialyzer 7005 is pumped through
tube 7002 past a blood temperature sensor 7012, air eliminator 7013
and air (bubble) sensor 7014 and back to a vein of the patient. A
pinch valve 7016 is also placed before circuit connection of the
patient to completely stop blood flow if air is sensed by the air
(bubble) sensor 7014 in the line upstream of the pinch valve 7016
thereby preventing the air from reaching the patient.
The dialysate circuit comprises two dialysate pump segments 7026,
7027 in pressure communication with pumps. Dialysate pump segments
7026, 7027 draw spent dialysate solution from the dialyzer 7005 and
the regenerated dialysate solution from reservoir 7034
respectively. Spent dialysate from the outlet of the dialyzer 7005
is drawn through blood leak sensor 7028 to reach bypass valve 7029.
Flow sensor 7030 is one of two flow sensors (the other being flow
sensor 7046) which determine the volume of dialysate flowing
through the circuit. Valve 7030 is similar in construction to a
two-way valve and is used to bypass dialysate pump 7026. Valve 7030
is normally closed in the direction of the bypass. In the event the
dialysate pump 7026 is stopped, valve 7030 is opened to direct flow
around pump 7026. Pressure sensor 7031 is placed between the flow
sensor 7030 and the valve 7030. During normal flow, the spent
dialysate is pumped via pressure sensor 7040 and through sorbent
cartridges 7015 where the spent dialysate is cleansed and filtered.
The cleansed/filtered dialysate then enters reservoir 7034. An
ultrafiltrate pump 7032 is operated periodically to draw
ultrafiltrate waste from the spent dialysate and store in an
ultrafiltrate bag (not shown) that is emptied periodically.
Regenerated dialysate from the reservoir 7034 passes through flow
restrictor 7035, dialysate temperature sensor 7044, flow sensor
7046 and pressure sensor 7036 to reach two-way valve 7045 through
bypass valve 7041. When the respective flow paths of bypass valves
7029, 7045 and 7041 are activated they direct regenerated dialysate
to bypass the dialyzer 7005. Infusate and concentrate streams from
infusate and concentrate reservoirs 7050, 7051 are directed by
infusate and concentrate pump segments 7042, 7043 into the cleansed
dialysate emanating from the reservoir 7034 and the spent dialysate
downstream of flow sensor 7030, respectively.
The two-way valve 7045 determines what mode the system is operating
in. Thus, in one mode of operation the two-way valve 7045 allows
the regenerated dialysate to enter dialyzer to enable normal
hemodialysis of the patient's blood. In another mode of operation,
the two-way valve 7045 is actuated to direct fluid flow of ultra
pure infusate grade dialysis fluid into the venous blood line and
directly to patient. Accordingly, the versatile valves enable the
mode of operation to switch between hemofiltration and
hemodialysis. For example, in hemofiltration, infusible grade fluid
is routed through the three valves directly into the blood stream
where valve 6946 connects to the post dialyzer. In this mode valve
6945 prevents the dialysate fluid from entering the lower port of
the dialyzer. In hemodialysis, shown in FIG. 13, valve 6946 is
closed and valves 6947 and 6945 route dialysate fluid to the
dialyzer. It should be noted that the embodiment of FIG. 13 uses
pump swapping and a plurality of valves to control fluid volume
while the embodiment of FIG. 14 uses flow sensors 7030 and 7046 to
control fluid volume.
As discussed above, valves are preferably implemented in a manifold
using elastic membranes at flow control points which are
selectively occluded, as required, by protrusions, pins, or other
members extending from the manifold machine. In some cases, fluid
occlusion is enabled using a safe, low-energy magnetic valve.
The valve system comprises a magnetic displacement system that is
lightweight and consumes minimum power, making it ideal even when
the portable kidney dialysis system uses a disposable manifold for
fluidic circuits. The system can be used in conjunction with an
orifice in any structure. In particular, an orifice is any hole,
opening, void, or partition in any type of material. This includes
pathways in tubing, manifolds, disposable manifolds, channels, and
other pathways. One of ordinary skill in the art would appreciate
that the presently disclosed valve system would be implemented with
a disposable manifold by positioning the displacement member and
magnets, as further discussed below, external to the manifold at
the desired valve location. The actuator is also separate and
distinct from the disposable manifold and generally part of the
non-disposable portion of the kidney dialysis system.
Functionally, the valve has two stable states: open and closed. It
operates by using magnetic forces to move a displacement member
against a diaphragm and thereby create sufficient force to press
the diaphragm against a valve seat and cause the diaphragm to close
the orifice. Closing of the orifice shuts off fluid flow. The
reverse process, namely the use of magnetic forces to move a
displacement member away from the diaphragm and thereby release the
diaphragm from compression against the valve seat, opens the
orifice and permits fluid to flow.
FIG. 15 is a flowchart showing another process 8000 for initiating
a dialysis treatment. The controller unit 8001 can comprise at
least one processor and memory storing a plurality of programmatic
instructions. When executed by the processor, the programmatic
instructions generate a plurality of graphical user interfaces,
displayed on the controller display, which directs a user through a
series of actions designed to reliably acquire and measure the
additives required for use in a dialysis treatment. A first
graphical user interface is generated through which a user can
prompt the system to initiative the additive accounting process
8001. The initial prompt can be through a specific icon for
initiating the process or can occur as part of a larger system
setup.
A second graphical user interface is then generated 8003 which
displays in text or graphical form the additives required,
preferably including a visual image of the actual additive package
to permit a user to visually compare the additive required with the
product the user has on-hand. The user is then prompted 8005 to
indicate whether he wishes to verify the additive using a bar code
scan or by weight. If the user indicates he wishes to use the bar
code scan, through, for example, pressing an icon, a third
graphical user interface is generated 8007 prompting the user to
pass the first additive past the bar code scanner. The user then
passes an additive, preferably in any order, past the bar code
scanner, registering a read. It should be appreciated that the bar
code scanner can comprise a light, such as a red light, which
changes color, such as to green, upon a successful reading.
If the system successfully reads the bar code it processes 8009 the
code by checking the code against a table stored in memory. The
table stored in memory associates bar codes with specific
additives. Once a specific additive is identified, the second
graphical user interface, as described above, is updated 8011 with
a check mark or highlight to indicate which additive has been
successfully scanned and the user is instructed to set the additive
aside. This process is repeated 8019 for all additives. In one
embodiment, once all additives are highlighted or checked, the
system automatically proceeds to the next step in the dialysis set
up or initialization process. In another embodiment, once all
additives are highlighted or checked, the system presents a
graphical user interface informing the user that all additives have
been registered, after which a user causes the system to manually
proceed to the next step in the dialysis set up or initialization
process. It should be appreciated that, while the term bar code is
used, any electronic tagging or labeling system can be used,
including, for example, radio frequency identification (RFID)
tags.
If, for any scanning step 609, the bar code is not recognized, the
additives do not have bar codes, or the user prefers to verify
additives using weighing, as opposed to scanning, a graphical user
interface is presented to the user prompting 8013 the user to place
a first additive on the scale. The scale measures the additive
package weight 8015 and compares the measured weight to a table of
weight values associated with specific additives in order to
recognize the additive. Once recognized, the second graphical user
interface, as described above, is updated 8017 with a check mark or
highlight to indicate which additive has been successfully scanned
and the user is instructed to set the additive aside. This process
is repeated 8019 for all additives. In one embodiment, once all
additives are highlighted or checked, the system automatically
proceeds to the next step in the dialysis set up or initialization
process. In another embodiment, once all additives are highlighted
or checked, the system presents a graphical user interface
informing the user that all additives have been registered, after
which a user causes the system to manually proceed to the next step
in the dialysis set up or initialization process. It should be
appreciated that, while the term bar code is used, any electronic
tagging or labeling system can be used.
If the additive is not recognized, the user is informed that the
additive is not part of the treatment process and is prompted to
weigh a proper additive. In another embodiment, if the user fails
to scan or weigh a recognized additive, the user is not permitted
to continue the initialization or set up process.
One of ordinary skill in the art would appreciate that although the
aforementioned verification procedure has been described for
prescription additives, the same procedure may also be extended to
the disposable components used with the dialysis system, such as
sorbent cartridges and other disposables.
It should further be appreciated that the process of scanning and
weighing the additives can be integrated and automated. As
discussed above, a user can be prompted to initiate the additive
weighing process and a display of items needed for treatment may be
displayed. A user places an additive on a scale which has a bar
code reader proximate to or integrated therein. In one embodiment,
the user is prompted to place the additive in a specific position
or configuration to ensure the bar code can be properly read. Upon
placing the additive on the scale having an integrated or combined
bar code reader, the bar code reader scans the additive, attempts
to recognize the bar code, and, if recognized, processes the item
by checking or highlighting the identified additive on the display.
If the bar code reader fails to identify the additive, if the
system requires an additional, supplemental check, or if the system
wishes to obtain or otherwise record weight information, the scale
measures the weight and attempts to recognize the additive against
stored values. If identified, the system processes the item by
checking or highlighting the identified additive on the display.
The scale measurement and bar code reader can therefore occur
without having to move the additive from one location or position
to another.
It should further be appreciated that the additives can be inserted
into a holding container, chute, cylinder, box, bucket, or staging
area that will automatically drop, place, or otherwise position
each additive into the appropriate position on a scale/bar code
reader. Accordingly, the user can place all additives into a single
container, activate the system, and have each additive sequentially
positioned on the scale and identified automatically. A user may be
prompted to remove each additive after each additive is recognized
or may be prompted to allow all additives to be processed
first.
It should further be appreciated that the additive can be added to
the system automatically after identification, manually after
identification, and either before or after the hemofilter and/or
sorbent cartridge is installed. In one embodiment, the top or
bottom unit of the portable dialysis system also preferably has
electronic interfaces, such as Ethernet connections or USB ports,
to enable a direct connection to a network, thereby facilitating
remote prescription verification, compliance vigilance, and other
remote servicing operations. The USB ports also permit direct
connection to accessory products such as blood pressure monitors or
hematocrit/saturation monitors. The interfaces are electronically
isolated, thereby ensuring patient safety regardless of the quality
of the interfacing device.
In another embodiment, the dialysis machine comprises an interface,
in the form of a graphical user interface with touch screen
buttons, physical keypad, or mouse, which can be manipulated to
cause a dialysis machine loaded with a manifold to start operation
in either a treatment mode or priming mode. When instructed to
operate in treatment mode, the controller generates a signal (in
response to that treatment mode command) to cause the manifold
valve to switch from an open, priming state to a closed, treatment
state. When instructed to operate in priming mode, the controller
generates a signal (in response to that priming mode command) to
cause the manifold valve to switch from a closed, treatment state
to an open, priming state. One of ordinary skill in the art would
appreciate that all of the aforementioned control and user command
functions are effectuated by incorporating one or more processors,
executing programming embodying the aforementioned instructions,
which are stored in local memory.
When properly actuated, the system can operate in at least a
priming mode and a treatment mode, which can comprise other modes
of operation (such as hemodialysis, hemofiltration, or, simply, a
non-priming mode).
Embodiments of the dialysis systems disclosed herein can be
designed to use a plurality of disposable components. Disposables
for use in the system can be shipped in packaging preassembled on a
tray. The tray can be placed on top of the controller unit
workspace, thereby permitting easy access to, and management of,
the required disposables, which is of particular importance inside
a vehicle. The controller unit can be waterproof rated, so that, in
case of a liquid spill, liquid will not seep into and damage the
controller unit.
In an exemplary embodiment, shown in FIG. 16, a disposable kit 8200
is provided that contains a manifold 8202, dialyzer 8201, and
tubing 8203 which are all preattached. Referring to FIG. 16, the
disposable kit 8200 comprises a dialyzer 8201, manifold 8202,
tubing 8203, valves 8204 (as part of the manifold), reservoir bag
8205, which are all preattached and configured for direct
installation into the dialysis machine by a user.
The disposable components, particularly the fully disposable blood
and dialysate circuits, can be prepackaged in a kit (which includes
dialyzer, manifold, tubing, reservoir bag, ammonia sensor, and
other components) and then installed by a user by opening the front
door of the unit, installing the dialyzer and installing the
manifold in a manner that ensures alignment against non-disposable
components such as pressure, sensors, and other components. A
plurality of pump shoes integrated into the internal surface of the
front door makes loading of disposable components easy. The
manifold only needs to be inserted and no pump tubing needs to be
threaded between the rollers and shoes. This packaged, simple
approach enables easy and quick disposables loading, and cleaning
of the system. It also ensures that the flow circuitry is properly
configured and ready for use. In operation, a separate unit,
receptacle, trunk, glove box, or cabinet can be provided to house
the reservoir.
With respect to an exemplary treatment mode and referring to FIG.
17, the dialysis system 8400 operating in dialysis mode comprises a
dialyzer 8402, sorbent regeneration system (e.g. cartridge) 8412,
manifold 8410, infusate source 8416 entering into the manifold 8410
through a port, and reservoir 8415 from which fresh dialysate is
input back into the manifold 8410 via a port. In operation, blood
enters the blood line 8401, into the manifold 8410 through a port,
through a two-way valve 8421 which is in a first position, and into
the dialyzer 8402. The purified blood exits the dialyzer 8402
through outlet 8403, through a two-way valve 8422 which is in a
first position, and into the manifold 8410 through a port. The
blood passes through the manifold, passing through a plurality of
valves, as described above in relation to manifold 8410, and out of
a port and into a blood line 8423 entering the patient.
Concurrently, infusate passing from a source 8416 passes into the
manifold 8410 through a port, through the manifold 8410, out
through another port, and into reservoir 8415, from which dialysate
is delivered via a dialysate in-line 8424 and into dialyzer 8402.
After passing through the dialyzer 8402, the dialysate passes
through an out-line 8425 and back into the manifold 8410 through a
port where it is routed to the sorbent-based dialysate regeneration
system 8412 via a port. Regenerated dialysate passes back through
the manifold 8410 via a port and is recirculated through the
dialyzer 8402 with new dialysate, if and when required. To manage
dialysate fluid flow, a reservoir 8415 is used to store regenerated
dialysate, if and when needed. In some embodiments, the reservoir
can hold 5 liters of dialysate and has the capacity to hold up to
10 liters of dialysate and effluent from the patient.
With respect to an exemplary priming mode and referring to FIG. 18,
a dialysis system 8500 operating in priming mode comprises a
dialyzer 8502, sorbent regeneration system (e.g. cartridge) 8512,
manifold 8510, infusate source 8516, and reservoir 8515. In
operation, the bloodline from the patient (e.g. 8401 in FIG. 17)
into the manifold 8510 is not connected and therefore, no blood is
flowing, or capable of flowing, into the manifold 8510. Rather,
dialysate passing from a source 8515 passes into the manifold 8510
through a plurality of ports and through a dialysate in-line 8524,
which is connected to the two-way valve port 8522.
A single two-way valve can be incorporated into the physical body
of the manifold and manipulated to switch between a treatment mode
of operation and a priming mode of operation. In this embodiment, a
manifold comprises a two-way valve which, if activated or switched
from a first positioned (e.g. closed) to a second position (e.g.
open), causes a change to the internal flowpath of liquid within
the manifold. As a result of this flowpath change, the blood and
dialysate circuits, which, when the valve is closed, are
fluidically isolated from each other, are now placed in fluid
communication with each other. Preferably, no additional valves or
switches need to be manipulated in order to achieve this state
change, namely, to cause separate blood and dialysate circuits to
become fluidly connected.
The valve switch may be effectuated by any means known in the art,
including by physically manipulating a mechanical control on the
surface of the manifold or electronically through the operation of
a dialysis machine causing a change to the valve state through an
interface between the dialysis machine, which has a controller to
control the state of the valve in accordance with a user-selected
operational mode, and a valve interface integrated into the surface
of the manifold.
In priming mode, the valve would be opened, thereby causing
dialysate fluid flowing through a pump to pass through the
manifold, into the dialyzer, out of the dialyzer, back into the
manifold, and out of manifold. Accordingly, in the priming mode,
the valve ensures that the dialysate circulates through the blood
circuit, thereby placing the blood and dialysate circuits in fluid
communication. Functionally, the manifold is placed in priming
mode, by manipulating the state of the two-way valve.
After a specified volume of dialysate is pumped into and through
the blood circuit, the two-way valve is closed. Pumping of
dialysate may or may not continue. If continued, the fresh
dialysate circulates through the dialysate circuit only. In the
blood circuit, residual dialysate remains To purge the dialysate
from the blood circuit, a patient is connected to the "From Patient
Line" 8401, shown in FIG. 84 and typically referred to as the
arterial access line. The "To Patient Line" 8423, typically
referred to as the venous return line is either held over a waste
container or connected to a patient.
Placing the system in treatment mode, blood from the patient is
drawn into the blood circuit, passing into the manifold, through
pumps, out of the manifold, through the dialyzer, back into the
manifold, and back out of the manifold. The blood thereby causes
the residual priming fluid to be `chased` through the blood
circuit, removing any remaining air pockets in the process, and
into either a waste container or the patient, depending on the
connected state of the venous return line. After blood has
completely filled the blood circuit, the system stops the blood
pump or the user stops the pump manually. If not already connected,
the venous return line is then connected to the patient and the
treatment continues.
In another embodiment, a filter, such as a 0.22.mu. filter, can be
used to help remove any remaining undesirable substances if the
sorbent-canister is inadequate to produce essentially sterile
dialysate. As an example, the filter is positioned in-line with the
reservoir input line, proximate to Port E of the manifold, and is
used both during priming and operation.
By using this priming system, one avoids having to use an
additional and separate set of disposables to just prime the blood
side of the circuit. In particular, this approach eliminates the
need for a separate saline source, such as a 1 liter bag of saline,
and, accordingly, also eliminates the need for connectors and
tubing to the separate saline source, including dual-lumen spikes
or single lumen spikes used to connect blood lines to the
saline.
FIG. 19 depicts, among other elements, a disposable conductivity
sensor 8690 comprising a tubular section with a first end for
receiving a first disposable tubing segment and a second end for
receiving a second disposable tubing segment. The tubular section
comprises a first plurality of probes that extend into the interior
volume defined by the tubular section and constitute the fluid
flowpath. In one embodiment, at least three separate, elongated
probes are employed. In another embodiment, at least four separate,
elongated probes are employed.
The disposable conductivity sensor 8690 is adapted to attach to a
complementary, mating second plurality of probes that are fixedly
and/or permanently attached to the exterior side of the control
unit. The site of attachment can comprise a portion of the exterior
surface of the control unit proximate to, or on the same side as,
the dialyzer. Operationally, disposable conductivity sensor 8690 is
snapped into a temporary, but attached, relation to the
complementary, mating non-disposable plurality of probes.
Therefore, the second plurality of probes is received into, and
positioned in communication with, the first plurality of probes.
The probes then operate by emitting and detecting signals within
the fluid flow path defined by the first disposable tubing segment,
tubular section of the conductivity sensor, and second disposable
tubing segment, and then transmitting detected signals to a memory
and processor within the control unit for use in monitoring and
controlling the dialysis system.
Referring to FIG. 19, a method and system for safely and
efficiently performing a saline rinse back is shown.
Conventionally, a saline rinse back, which serves to flush the
system with saline, is performed by detaching a tubular segment
8658 that connects the dialysis blood circuit to the patient at
connection 8651 and attaching the tubular segment 8658 to a saline
source 8602 via connection points 8652 and 8653. This conventional
approach has disadvantages, however, including the breaching of a
sterile connection. It should be appreciated that the connection
points can be any form of connection, including luer connections,
snap fits, needle-less inserts, valves, or any other form of
fluidic connection.
Another approach to a saline rinse back includes connecting the
saline source 8602 via connection point 8652 to connection point
8653, while maintaining the connection to the patient. While it
avoids breaching the sterile connection, it exposes a patient to a
saline fluid flow. Accordingly, a preferred approach to performing
a saline rinse back is to maintain the blood circuit connection
between the patient and the dialysis system via tubular segment
8658, which connects to the manifold 8600 at port C 8605 and the
patient at connection point 8651 and fluidically connects the
saline source 8602 to the manifold 8600 at port D 8606. With the
patient still fluidically connected to the dialysis system, saline
is permitted to flow, by gravity or applied pressure, into the
manifold 8600 via port D 8606, which is adjacent to port C 8605.
The saline flow serves to flush the manifold 8600 with saline and,
in particular, to flow out of the manifold 8600 via port C 8605,
through tubular segment 8658, and into the patient via connection
8651. Because an air bubble detector is present in region 8654,
proximate to port C 8605, when the manifold 8600 is installed in
the controller unit and therefore adapted to detect air bubbles in
fluid flow exiting port C 8605, saline exiting the manifold 8600
and toward the patient will be monitored for air bubbles, via the
air bubble detector in region 8654. If an air bubble is detected, a
low level alarm will sound, thereby signaling to a patient that he
or she should either disconnect from the system or extract the air
bubble, using a syringe, from access point 8610. Accordingly, this
method and system for conducting a saline rinse back maintains a
sterile connection while still monitoring and alarming for the
presence of air bubbles.
The entire contents of all references cited in this disclosure are
incorporated herein in their entireties, by reference. Further,
when an amount, concentration, or other value or parameter is given
as either a range, preferred range, or a list of upper preferable
values and lower preferable values, this is to be understood as
specifically disclosing all ranges formed from any pair of any
upper range limit or preferred value and any lower range limit or
preferred value, regardless of whether ranges are separately
disclosed. Where a range of numerical values is recited herein,
unless otherwise stated, the range is intended to include the
endpoints thereof, and all integers and fractions within the range.
It is not intended that the scope of the invention be limited to
the specific values recited when defining a range.
Other embodiments of the present invention will be apparent to
those skilled in the art from consideration of the present
specification and practice of the present invention disclosed
herein. It is intended that the present specification and examples
be considered as exemplary only with a true scope and spirit of the
invention being indicated by the following claims and equivalents
thereof.
* * * * *